2015 ISPE
Annual Meeting
8–11 November 2015 • Philadelphia, Pennsylvania USA
ON-SITE EVENT GUIDE
ISPE: The Center
of Pharmaceutical Solutions
New Paradigms
for Manufacturing
Excellence
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ISPE Annual Meeting 2015
Don’t Miss...
2015
Awarded by ISPE
FOYA
Facility of the Year Awards
Monday, 9 November, 08.30 - 10.00
FOYA Education Session
Tuesday, 10 November, 08.00 - 10.00
Overall FOYA Winner Announcement
Learn about the innovative projects from the 2015 Facility of
the Year Awards Category Winners. Be among the first to
learn which project will be named the 2015 Facility of the Year
Awards Overall Winner. The FOYA Program recognizes stateof-the-art pharmaceutical manufacturing projects utilizing
new and innovative technologies to improve product quality,
reduce cost and demonstrate advances in project delivery.
Deadline for Submissions is 23 November, 2015
Submit an entry for the 2016 ISPE Facility of
Year Awards!
Table of Contents
For full program information and submission criteria,
visit www.FacilityoftheYear.org today!
4 Keynote Session
Business Continuity Planning for the Prevention
of Drug Shortages: Introducing the ISPE Drug
Shortage Assessment and Prevention Tool
6 Schedule at a Glance
7-27 Education Sessions
Monday, 9 November, 10.45 – 12.15
In this session, ISPE will roll out its NEW Drug Shortage
Assessment and Prevention Tool to take drug shortage prevention
from theory to practice. This easy-to-use tool identifies points to
consider when assessing the gap between current operations
and the desired state of a robust quality system, including specific
metrics, supportive quality culture, appropriate business continuity
plans, and well-qualified and trained employees.
30-32 ACPE Accreditation
33 Training
34 Exhibit Hall
Download your copy at:
35-66 Exhibitor Directory
67 Hotel Map
70-73 Event Schedule
74 General Information and
Onsite Services
76 Young Professionals and
Students Schedule and Events
77 Networking Events
78 Facility Tours Plus Philadelphia
Excursions
80 Affiliate/Chapter Council
Information
84-85 Thank You to Our Sponsors
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www.ISPE.org/2015AnnualMeetingHandouts
Membership Breakfast and Awards Ceremony with Drawing
Tuesday, 10 November, 08.00 – 10.00
Preview of next year’s Annual Meeting location and prize
drawing at the end of the breakfast. Must be present to win.
Doors Close at 08.25
Special Topics
Don’t miss these series of sessions addressing related topics:
(See Education Sessions section for more information.)
BIOPHARM
CHINA/ASIA-PACIFIC FACILITIES
DATA INTEGRITY
METRICS
RISK-BASED APPROACHES
SINGLE-USE TECHNOLOGIES
3
Thank You to the
2015 Planning Team
Members!
Strategy Committee
Opening Keynote
Session
Sunday, 8 November, 15.00 – 17.00
Grand A–F (Level 5)
Kathryn Wengel
Worldwide Vice President
Johnson & Johnson
Supply Chain
Quality as a Competitive Advantage in Supply Chain
François Sallans, Honorary Chair, VP Quality & Compliance,
Chief Quality Officer, Johnson & Johnson
Timothy P. Howard, PE, CPIP, Annual Meeting Chair, Vice
President, Global Operations, Commissioning Agents, Inc.
Arthur (Randy) D. Perez, PhD, Annual Meeting Co-Chair,
Director, Information Governance-Management, Novartis
Pharmaceuticals
James A. Gazvoda, Education Chair, Principal, Flad
Architects
Charles P. Hoiberg, PhD, Regulatory, Executive Director,
Pfizer, Inc.
Tiffany L. Coleman, Young Professionals, Project Manager/
Validation Specialist III, CGMP Validation LLC
Alan S. Levy, Social, Senior Program Manager, Mace North
America
David W. McAlonan, Chapters & Affiliates, Associate
Director GPRD, AbbVie
Mark Andrew O’Donnell, Exhibits & Sponsors, President,
Azzur Group LLC
Shannah Schodle, Marketing, Director Business
Development, CRB
Education Program Committee
Education Chair
James A. Gazvoda, Principal, Flad Architects
Track Directors
John G. Cox
Executive Vice President
Pharmaceutical Operations
and Technology
Biogen
Transforming Biologics Manufacturing to Deliver
on a Global Biopharmaceutical Pipeline: Biogen’s
Strategy for Success through Innovation
4
ISPE Annual Meeting 2015
Innovation Forum: Keith Gibbs, Director of Project
Delivery, Innovative Process Solutions
Facilities and Equipment: Michelle Gonzalez, PE,
BioPharm Engineering Consultant
Regulatory Compliance & Quality Systems:
Eric Thostesen, Senior Director, Regulatory Compliance,
Janssen Pharmaceuticals, Inc.
Product Development & Production Systems:
Steven Miller, CPIP, Director, MedImmune/AstraZeneca
Supply Biologics
Information Systems: Mike Rutherford, Consultant –
MDU – Business Systems, Eli Lilly & Co.
End-to-End Supply Chain Management: Noreen
Mallabar, Global Relationship Director, Fisher Clinical
Services, Inc.
Conference Essentials
1. Review education sessions and exhibit
hall floor plan and plan your schedule
2. Purchase special events at the Registration Desk before they sell out
3. Connect to wireless network
4. Attend the Opening Keynote Session on Sunday afternoon
OFF GUIDANCE
DOCUMENTS
ISPE Members receive 20% off all Guidance Documents
purchased on site. Stock up and take advantage of the
savings! Visit the Bookstore to purchase.
Wireless Access:
SSID: ISPEWiFibyCAI
Password: cai@224
Sponsored by:
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5
Schedule at a Glance
SUNDAY, 8 NOVEMBER
08.30 – 09.30
International Student Poster
Competition Set-Up
07.30 – 07.45
Young Professionals Meet
and Greet
12.30 – 13.30
Young Professionals/Students
Luncheon and Orientation
08.00 – 10.00
Membership Breakfast and
Ceremony
15.00 – 17.00
OPENING KEYNOTE SESSION
09.30 – 16.00
Exhibit Hall Open
Welcome Reception in the
Exhibit Hall
10.00 – 10.45
Networking Break in the
Exhibit Hall
10.45 – 12.15
EDUCATION SESSIONS
12.15 – 13.30
Lunch in the Exhibit Hall
13.30 – 15.00
EDUCATION SESSIONS
15.00 – 16.00
Networking Break in the
Exhibit Hall
16.00 – 17.30
EDUCATION SESSIONS
18.45 – 22.00
Tuesday Night Party at
Reading Terminal Market
(Meet in Lobby for a special
performance)
17.00 – 19.00
MONDAY, 9 NOVEMBER
6
TUESDAY, 10 NOVEMBER
06.30 – 08.00
7th Annual ISPE Charity 5K
Run/Walk (07.00 start; buses
depart 06.30)
07.00 – 08.30
Grab-and-Go Coffee Plus
Option to Purchase Food
07.15 – 08.15
New Member and First-Time
Attendee Orientation and
Networking Breakfast
08.15 – 08.30
Young Professionals Meet
and Greet
08.30 – 10.00
EDUCATION SESSIONS
09.30 – 18.30
Exhibit Hall Open
10.00 – 10.45
Networking Break in the
Exhibit Hall
10.45 – 12.15
EDUCATION SESSIONS
12.15 – 13.30
WEDNESDAY, 11 NOVEMBER
07.00 – 08.30
Grab-and-Go Coffee Plus
Option to Purchase Food
08.30 – 10.00
EDUCATION SESSIONS
10.00 – 10.30
Networking Break in the
Exhibit Hall
Lunch in the Exhibit Hall
10.30 – 12.00
EDUCATION SESSIONS
13.30 – 15.00
EDUCATION SESSIONS
09.00 – 20.00
13.30 – 17.00
International Student Poster
Competition
Facility Tour #1– Merck’s Gardasil
Vaccine Production Facility
09.40 – 16.00
15.00 – 16.00
Networking Break in the
Exhibit Hall
Facility Tour#2– Morphotek’s
Sustainable
2013 Facility of the Year
16.00 – 17.30
Global Regulatory Town Hall –
General Education Session for
All Delegates
09.40 – 20.00
Facility Tour #3– AstraZeneca’s
New Formulation Suite
Facility Tour
17.30 – 18.30
Mix and Mingle Reception in
the Exhibit Hall
19.30 – 22.00
Young Professionals Event at
Lucky Strike
ISPE Annual Meeting 2015
Education Sessions
Special Topics Key:
BIOPHARM
DATA INTEGRITY
CHINA/ASIA-PACIFIC FACILITIES
METRICS
SSessions
RISK-BASED APPROACHES
SINGLE-USE TECHNOLOGIES
YOUNG PROFESSIONALS FRIENDLY
Sunday, 8 November
Facilities and Equipment Track
15.00 – 17.00 OPENING KEYNOTE SESSION
1-109: FACILITY OF THE YEAR
(FOYA) 2015 CATEGORY WINNERS
Room: Grand L (Level 5)
• Kathryn Wengel, Worldwide Vice President
Johnson & Johnson Supply Chain
Quality as a Competitive Advantage in Supply Chain
• John G. Cox, Executive Vice President
Pharmaceutical Operations and Technology, Biogen
Transforming Biologics Manufacturing to Deliver on a Global Biopharmaceutical Pipeline: Biogen’s Strategy
for Success through Innovation
Monday, 9 November
08.30 – 10.00 EDUCATION SESSIONS
Innovation Forum Track
6-601: THE FUTURE OF PHARMA
MANUFACTURING – THE NEXT 100
YEARS Room: Grand I (Level 5)
Rapid change is impacting the pharmaceutical industry.
In this highly visual presentation, four areas will be
discussed that will drastically impact the future of the
pharmaceutical industry. These four areas include:
1) the development of medicines in outer space
2) the Internet of Things (IoT)
3) the use of Big Data tools
4) the maker movement
In addition, we will discuss challenges that will impact
innovation in the pharmaceutical industry.
• Leader: Keith Gibbs, Director of Project Delivery, Innovative Process Solutions, USA
• Dean Calhoun, CIH, President and CEO, Affygility Solutions, USA
The Future of Pharmaceutical Manufacturing: The Next 100
Years. Why You Need to be Planning for the Future Now
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2015
Awarded by ISPE
Get an in-depth look at the latest, state-of-the-art
developments being implemented, the winning projects,
and see how excellence was delivered via innovative
thinking. Featured presentations include the 2015 Facility
of the Year Awards Program Category Winners.
• Leader: Dave DiProspero, Sr. Pharmaceutical
Specialist, CRB, USA
• Takeshi Furukawa, Director of Engineering,
Astellas Pharma Inc., Japan
Tube Labeling Project
• Martin Teo, Project Director, AstraZeneca, China
AstraZeneca Taizhou Supply Site Project –
Innovative Project Execution Tailored to China Market
1-101: MANAGING ABSTRACT
ELEMENTS BEYOND FACILITIES
Room: Grand G (Level 5)
Increasing the industry’s knowledge base of best
management practices for “non-building” project types,
i.e.; the Abstract. Abstract project presentations will
focus on the unique characteristics, challenges, risks and
lessons learned on each project. The track will promote
PM Good Practice Guide philosophies as critical skills
needed by all to deliver controlled and predictable results.
The session will identify the value of the ISPE Project
Management Good Practice Guide.
• Leader: James McGlade, Science Client Leader,
BHDP Architecture, USA
L
eader: Alfred Penfold, BSc, MBA, Director,
Global Engineering, Pfizer, Inc., United Kingdom
Managing Abstract Elements Beyond Facilities
• Patrick Donnelly, Client Leader, BHDP Architecture, USA
Riding the Change Continuum Loop
• Edmond O’Leary, Director PGE, Pfizer, Inc., USA
Managing Abstract Elements of a Facility of the
Year Award Winner
7
Regulatory Compliance and Quality Systems Track
Product Development and Production Systems Track
2-201: COMBINATION PRODUCTS:
SAME VOCABULARY, DIFFERENT
Room: Liberty C (Level 3)
INTERPRETATION
3-301: IMPLEMENTING SINGLE-USE
TECHNOLOGY IN SCALE-UP
FROM CLINICAL TO COMMERCIAL
Room: Grand K (Level 5)
MANUFACTURING
There are some expectations that both Pharm-Centric
and Device-Centric organizations have in common under
the FDA Guidance on Combination Products. These
types of organizations may use the same words, but
they are interpreted differently. This creates confusion in
implementation of 21 CFR part 4. This session will explore
the various interpretations and how to address differing
expectations for implementation.
• Leader: Susan Neadle, FAAO, FBCLA, Sr. Director,
DtV & PQM; Head, Combination Products CoE,
Janssen Pharmaceuticals, Inc., USA
Combination Products: Same Vocabulary, Different
Interpretation
• Paul Burke, Director of Quality, Medtronic, Ireland
Combination Products: A Manufacturer’s Perspective
• Melissa Burns, Senior Program Management,
FDA/CDER/OC/OMPT/OSMP/OCP, USA
FDA Updates on Combination Product Guidance and
Enforcement Approaches
2-217: LATEST TRENDS FROM FDA IN
COMPLIANCE, ENFORCEMENT, cGMPs
AND QUALITY SYSTEMS Room: Grand H (Level 5)
Hear about the latest trends from both regulator and
industry perspective in compliance, enforcement, cGMPs
and quality systems.
• Leader: Peter Carbone, Vice President, Novartis
Pharmaceuticals, USA
Office of Manufacturing Quality CDER/OC: Latest
Initiatives and Trends in Enforcement
• Thomas Cosgrove, JD, Director, Office of
Manufacturing Quality, Office of Compliance,
FDA/CDER/OC/OMQ, USA
•Richard Friedman, Deputy Director, Science and
Regulatory Policy, FDA/CDER/OC/OMQ, USA
QMS and the Supply Chain
• Francis Godwin, Division Director, Division of Drug
Quality 2 (DDQ2), FDA/CDER/OC/OMQ, USA
OMQ Enforcement Trends and Strategic Priorities
8
ISPE Annual Meeting 2015
This session will focus on three current project “case studies”
and use examples of challenges/issues that were not
identified during conceptual development of the commercial
manufacturing design, yet had a significant impact on what
became reality.
• Leader: Jeffery Odum, CPIP, SME, Director of Operations,
Biotech Lead, IPS-Integrated
Project Services, Inc., USA
Things Your Mother Didn’t Tell You: Lessons Learned from
Implementing Single-Use Technology in Scale-Up from Clinical
to Commercial Manufacturing
• Donald Powers, Principal Scientist, Janssen Cell Therapy
• Lesley Wood, Head of Engineering, Lonza AG, Switzerland
Information Systems Track
4-401: PRAGMATIC APPROACHES TO DATA
INTEGRITY PART 1
Room: Grand J (Level 5)
Data integrity surrounding computer system supported
business processes has been at the forefront of recent news.
The awareness of these issues has changed the approach
used by regulators in conducting inspections in recent years.
Data integrity has become the focus of regulatory inspections
worldwide. The industry recognizes the need to ensure controls
for data integrity are implemented and managed throughout
the data lifecycle.
• Leader: Michael Rutherford, Consultant – MDU – Business
Systems, Eli Lilly & Co., USA
Leader: Lorrie Vuolo-Schuessler, Manager, Computer
Systems Quality Assurance, GlaxoSmithKline, USA
Pragmatic Approaches to Data Integrity
• Stacey Blackmer, Director, Computer Systems
Quality Assurance, GlaxoSmithKline, USA
Digital Imaging – GxP System Case Study Considerations
• Monica Cahilly, President, Green Mountain
Quality Assurance, LLC, USA
Measuring Effectiveness of Data Integrity Programs: Metrics
for Excellence
Education Sessions
End-to-End Supply Chain Management Track
5-501: PATIENT PERCEPTIONS OF
INVESTIGATIONAL MEDICINAL
PRODUCTS WITH REAL-WORLD
Room: Liberty A-B (Level 3)
APPLICATIONS
An initial ground-breaking survey into Patient Perception
of IMPs was undertaken in early 2013 and reported on at
the 2013 ISPE Annual Meeting. ISPE sponsored this survey
and the goal was to get a global perspective. While the
results were very helpful to the industry to ensure more
‘’patient-friendly” clinical supplies, unfortunately 97% of the
1,400 respondents were based in the US. This session will
now present results from additional surveys undertaken in
the UK, EU, China and Japan.
•L
eader: Esther Sadler-Williams, Global Director
Strategic Development, United Kingdom
•L
ynn Wang, Merck & Co., Inc., USA
The Patient Initiative: Results from 2015 Surveys In EU,
China and Japan to Assess Patient Perceptions of
Investigational Medicinal Products
•M
ichelle Foust, PharmD, Director of Supply Chain Strategy,
USA
Welcome and Introduction to the End-to-End Track
•B
eth Gardner, Director, Clinical Supply Strategy, Takeda
Pharma America Inc., USA
•P
eter Marschel, Decision Science, Takeda
Pharmaceuticals, USA
Bedside Manners: Using ISPE’s Patient Survey Data to
Improve Patient Experiences
Monday, 9 November
10.45 – 12.15 EDUCATION SESSIONS
Innovation Forum Track
6-602: MOVING BEYOND PARADIGM
PARALYSIS TO GAIN CONTROL OF THE
QUALITY CULTURE AND BEHAVIOR OF
YOUR MANUFACTURING WORKFORCE
Room: Grand I (Level 5)
The current solutions to Drug Shortage problems are
reactive – when one happens we fix it, often requiring atrisk medicines to be released to patients. This approach
is clearly not sustainable – a proactive solution is required.
The industry’s ability and commitment to move from the
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current compliance culture to a patient-centric quality
culture is key to maintaining consistent quality-focused
behavior across the manufacturing workforce. This handson workshop demonstrates a Behavioral Analysis and
Intervention Program tool that can measure the behavioral
traits necessary to work in a GMP regulated environment.
Case study data of industry’s experience in using this risk
mitigation tool in 2015 will be presented.
• Leader: Patricia Melton, BSc, MBA, PhD, Managing
Director, Mime Solutions, United Kingdom
• Gerard Creaner, President, GetReskilled, Inc., USA
Moving Beyond Paradigm Paralysis from a Compliance
Culture to a Quality Culture - How to Gain Control of
the Quality Culture and Behavior of Your Manufacturing
Workforce and Achieve Manufacturing Excellence
Facilities and Equipment Track
1-110: A DECADE OF DATA – FACILITY
OF THE YEAR (FOYA) AGGREGATE
METRICS
Room: Grand L (Level 5)
Presentations will provide valuable information concerning
facility costs and area metrics derived from the first ten
years of FOYA submissions.
• Leader: Larry Kranking, Vice President, International
Consulting, CAI, USA
Leader: James McGlade, Science Client
A Decade of Data – FOYA Submission Aggregate Metrics
1-102: CASE STUDY OF 12 FLEXIBLE
FACILITY BIOPHARM PROJECTS:
EMERGING TRENDS IN FLEXIBILITY FOR
STRATEGIC ADVANTAGE
Room: Grand G (Level 5)
Expanding pipelines with new and diverse products
introduce new flexible production requirements for the
biopharmaceutical industry’s manufacturing networks. The
industry is challenged to develop agile and truly flexible
facilities while ensuring significant reductions in schedule,
cost and operating resources.
• Leader: Niels Guldager, CPIP, Senior Technology Partner,
Biopharmaceuticals, NNE Pharmaplan A/S, Denmark
• Suyamburam Sathasivam, General Manager, R&D
Biotechnology, Sun Pharmaceutical Industries Ltd., India
Case Study: Impact of a Continuous Bioprocess
Flexible Facility
• Frank Nygaard, PhD, Senior Technology Partner,
Global Business Development, NNE Pharmaplan, Denmark
Case Study of 12 Flexible Facilities for Biopharma
Manufacturing
9
Regulatory Compliance and Quality Systems Track
Product Development and Production Systems Track
2-202: HOT TOPICS IN VALIDATION
PART 1: LIFECYCLE APPROACH TO
PROCESS VALIDATION – AVAILABLE
ISPE RESOURCES AND REMAINING
CHALLENGES Room: Liberty C (Level 3)
3-314: CURRENT TRENDS IN BARRIER
AND ASEPTIC TECHNOLOGIES
Pharma industry has made significant progress with
implementation of lifecycle approach to PV. The ISPE PV
team would like to raise awareness of tools developed
to assist with practical, compliant implementation and
provide a forum to discuss remaining challenges.
• Leader: Joanne Barrick, RPh, Advisor, Global
Validation, Eli Lilly & Co., USA
Lifecycle Approach to PV – Available ISPE Resources
and Remaining Challenges
• Lori Pfahler, Executive Director, Merck & Co Inc., USA
Statistically-Based Sampling Plans and Acceptance
Criteria for PPQ at Merck
•V
ibhakar Shah, Sr. Policy Advisor, FDA/CDER/OC/
DMPQ, USA
FDA Perspective on PV Lifecycle Implementation
Progress
2-212: BUSINESS CONTINUITY
PLANNING FOR THE PREVENTION OF
DRUG SHORTAGES: INTRODUCING THE
ISPE DRUG SHORTAGE ASSESSMENT
AND PREVENTION TOOL Room: Liberty C (Level 3)
This session will explore what companies can do to
help establish a reliable supply chain – one that will help
ensure the ability to continuously provide supply to meet
the needs of the market. ISPE will introduce its new
Drug Shortage Assessment and Prevention Tool. Using
the Tool to guide the conversation, a panel of industry
experts will focus on what their companies have done to
achieve business continuity.
• Leader: Sumanth Venugopal, Partner, Healthcare Practice, PricewaterhouseCoopers LLP, USA
• Harry Gill, Senior Vice President, Patheon
Pharmaceuticals, USA
• Sabine Haubenreisser, PhD, EMA-FDA Liason, DHHS/
FDA/OC/OGROP/OIP, USA
• David Lowndes, Senior Vice President, Supply Chain
Management, Shire
• Rod MacLea, Supply Chain Director, Amgen
10
ISPE Annual Meeting 2015
Room: Independence I-III (Level 3)
• Leader: Hite Baker, Principal Process Engineer, DME
Alliance Engineering Consultants, USA
L
eader: Jöerg Zimmermann, Vice President/
Bereichsleiter Vetter Development Service, Vetter
Pharma-Fertigung GmbH & Co. KG, Germany
Current Trends in Barrier and Aseptic Technologies
• Jennifer Culp, Director of Manufacturing - Aseptic
Filling Operations, Grifols Therapeutics Inc., USA
Implementation of New Aseptic Filling Technologies – Grifols
Sterile Filling
• James McCarley, PharmD, CEO, Cantrell Drug Company, USA
• Leslie Edwards, MSE, Sales Director, SKAN US, Inc., USA
• Jean-Sebastien Parisse, Sales Manager, Aseptic
Technologies, Belgium
Compounding Pharmacy: Aseptic Processing Upgrade
Case Study
•H
artmut Schaz, Senior Technology Partner, NNE
Pharmaplan GmbH, Germany
High Potent Fill & Finish 2.0
3-302: IMPACT OF SINGLE-USE
MANUFACTURING ON PROCESS
Room: Grand K (Level 5)
DEVELOPMENT
Economics favor all single-use manufacturing facilities
over conventional stainless steel facilities, yet process
development efforts don’t typically focus on single-use
implementation. Processes continue to be developed
that require conventional stainless steel equipment or
unnecessarily increase the cost of single-use facilities.
• Leader: Robert Bader, Senior Manager Technology
Pharma Bio, Jacobs Engineering Group Inc., USA
Leader: Steven Miller, CPIP, Director,
MedImmue/AstraZeneca Supply Biologics, USA
Robert Forbes, RA, Architectural Design Manager, Jacobs, USA
Impact of Single-Use Manufacturing on Process
Development
Education Sessions
Information Systems Track
4-402: PRAGMATIC APPROACHES TO
DATA INTEGRITY – PART 2
Room: Grand J (Level 5)
Data integrity surrounding computer system supported
business processes has been at the forefront of recent
news. The awareness of these issues has changed the
approach used by regulators in conducting inspections
in recent years. Data integrity has become the focus of
regulatory inspections worldwide. Industry recognizes the
need to ensure controls for data integrity are implemented
and managed throughout the data lifecycle.
• Leader: Michael Rutherford, Consultant – MDU –
Business Systems, Eli Lilly & Co., USA
Leader: Lorrie Vuolo-Schuessler, Manager, Computer
Systems Quality Assurance,
GlaxoSmithKline, USA
Pragmatic Approaches to Data Integrity – Session 2
•C
lemens Hohfelser, Global Business Owner
MES, Novartis Pharma AG, Switzerland
Data Integrity in Manufacturing Execution – A ProcessOriented Approach
• Robert McDowall, Director, RD McDowall
Ltd., United Kingdom
• Mark Newton, Associate Senior Consultant
QA, Eli Lilly & Co., USA
Laboratory Data Integrity: Regulations, Risks and Choices
End-to-End Supply Chain Management Track
5-502: TURNING THE PAGE FROM
PATIENT-UNFRIENDLY TO PATIENTFRIENDLY; MONITORING AND
ENHANCING COMPLIANCE IN CLINICAL
TRIALS Room: Liberty A-B (Level 3)
Monday, 9 November
13.30 – 15.00 EDUCATION SESSIONS
Innovation Forum Track
6-604: PART 1 - RAPID DEPLOYMENT
MODULAR OSD UNIT OPERATIONS;
PART 2 - HYBRID FACILITIES - AN
ECONOMICAL EVALUATION BETWEEN
SINGLE-USE AND REUSABLE PROCESS
Room: Grand I (Level 5)
EQUIPMENT
Part 1: Explore challenges and opportunities in the
manufacturing of small molecule products. Reduce
manufacturing and facility costs; reduce time and risk
in implementing new manufacturing lines; control core
intellectual property and quickly react to changing
market conditions
Part 2: This presentation will review an economical
evaluation to compare single-use technology with
reusable process equipment. By performing Total Cost
of Ownership calculations, one can determine which
solution is more economical in a particular application.
This case study evaluates several designs and reviews
run rate and other scenarios to determine when singleuse technology is more economical versus reusable
process equipment.
• Leader: Brian Beck, Manager/TL Project Engineer,
Zoetis Global Mfg and Supply, USA
• Pär Almhem, President, ModWave, USA
Rapid Deployment Modular OSD Unit Operations
• Ronald Berk, Vice President of Engineering,
Hyde Engineering + Consulting Inc., USA
Hybrid facilities - An Economical Evaluation
Between Single-Use and Reuse Process Equipment
• Kristen DeVito, Global Director, CSS Business Solns, Catalent Pharma Solutions, USA
Turning the Page from Patient-Unfriendly to
Patient-Friendly
• Rajneesh Taneja, Senior Director Product Development, TB Alliance, USA
Monitoring and Enhancing Compliance in CT
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11
Facilities and Equipment Track
1-111: THE LATEST OSD REGULATION
REQUIREMENTS AND TECHNOLOGIES
FOR PHARMA OPERATIONS
Room: Grand J (Level 5)
Today’s OSD Pharma manufacturers face numerous
challenges relating the global market demands for
increased production and multi-product change over
flexibility. Additionally, process and facility compliance
has been a key manufacturing operations issue with
direct impacts to product quality, safety and efficacy.
The new ISPE OSD Baseline Guide, Volume 3 provides
guidance and tools to help manufacturers drive towards
process and facility design decisions.
• Leader: Dave DiProspero, Senior Pharmaceutical
Specialist, CRB, USA
The Latest OSD Regulation Requirements and
Technologies for Pharma Ops: Introducing the New OSD
Baseline Guide 3rd Edition – 2015
• Jack Chu, PE, Associate Director, Engineering & Capital
Mgmt, MMD-WP, Merck & Co Inc., Engineering, MMD-WP,
USA
Applying the OSD Baseline Guide – A Big Pharma
Approach
• Richard Denk, Sales Manager Containment, SKAN AG
Switzerland
EU and US OSD Production and Protection
• Norman Goldschmidt, Principal, Genesis Engineers
Inc., USA
OSD Manufacturing Facility Classification Considerations
•R
obert Matje, CPIP, Vice President of Technical
Operations, Endo/Qualitest Pharmaceuticals, USA
Regulatory Considerations for Generic Pharma
OS Facilities
1-103: GMP IN AGING FACILITIES AND
UPGRADE OF EXISTING FACILITIES
Room: Grand L (Level 5)
Upgrading and renovation of existing manufacturing
sites is very relevant in the pharmaceutical industry
worldwide. Regardless of whether the upgrade is
performed in order to extend the facilities’ capacity or it
was necessary due to GMP issues, upgrading is much
more challenging than construction in the Greenfield.
This presentation will address these challenges and
propose “anti-aging” methods for securing the GMPcompliant status of facilities that evolve over time.
• Leader: Fatma Taman, General Manager,
PharmaVision Sanayi Ve Ticaret AS, Turkey
GMP in Aging Facilities & Upgrade of Existing Facilities
• Figen Ergin, Business Development Manager, Turkey
Implementation of Electronic Systems for High–Level
GMP Compliance
1-114: BAXTER INTEGRATED PLASMA
PROTEIN MANUFACTURING FACILITY:
THE HOME STRETCH Room: Grand G (Level 5)
Very large organizations like Baxalta are challenged to
be lean and to operate as efficiently as possible with
respect to staff headcount and spending. When large
new projects are initiated, subject matter experts are
“recruited” into an internal “volunteer army” to perform
schematic planning activities prior to the availability
of dedicated staff who are asked to add these
responsibilities to their already heavy loads. This causes
enormous stress in an organization.
• Leader: Javier Garay, Principal-Architectural
Designer, Flad Architects, USA
Integrated Plasma Protein Manufacturing Facility: The
Home Stretch
• Robert Chew, PE, President/CEO, Commissioning
Agents, Inc., USA
CQV Resource Management
• Kenneth Howerton, Senior Director, Quality,
Baxalta Inc., USA
Project Status, Key Challenges/Lessons Learned, Quality
Risk Management Approach Towards CQV
(Commissioning, Qualification & Validation)
• Eric Schnake, Engineering Director, Baxalta Inc., USA
Client to Owner – System Turnover
Special Topics Key:
12
BIOPHARM
DATA INTEGRITY
RISK-BASED APPROACHES
CHINA/ASIA-PACIFIC FACILITIES
METRICS
SINGLE-USE TECHNOLOGIES
ISPE Annual Meeting 2015
YOUNG PROFESSIONALS FRIENDLY
Education Sessions
Regulatory Compliance and Quality Systems Track
Product Development and Production Systems Track
2-216: HOT TOPICS IN VALIDATION
PART 2: LIFECYCLE APPROACH TO
PROCESS VALIDATION – AVAILABLE
ISPE RESOURCES AND REMAINING
CHALLENGES Room: Liberty C (Level 3)
3-303: SINGLE-USE STANDARDIZATION
UPDATE – AN INTERACTIVE PANEL
Room: Grand K (Level 5)
DISCUSSION
Pharma industry has made significant progress with the
implementation of lifecycle approach to PV. ISPE PV team
would like to raise awareness of tools developed to assist
with practical, compliant implementation and provide
a forum to discuss remaining challenges. The session
will include a summary of the ISPE/PQRI October PV
Conference along with progress and remaining issues.
• Andre Walker, CPIP, Director, Manufacturing Sciences,
Biogen, USA
Emerging Standards and Practices in Continued Process
Verification
2-213: CURRENT DATA INTEGRITY
TRENDS: A REGULATORY AND
COMPLIANCE PERSPECTIVE
Room: Grand H (Level 5)
• Leader: Crystal Mersh, President, Quality Executive
Partners Inc., USA
Regulator Perspective on Auditing for Data Integrity and
Criticality
• Karen Takahashi, Senior Policy Advisor, FDA/CDER/
OPQ/OPPQ/DRGS/Co., USA
Data Controls that Help Manage Data Integrity
• Stacey Blackmer, Director, Computer Systems Quality
Assurance, GlaxoSmithKline, USA
•M
onica Cahilly, President, Green Mountain Quality
Assurance, LLC, USA
•C
lemens Hohfelser, Global Business Owner MES,
Novartis Pharma AG, Switzerland
•R
obert McDowall, Director, R D McDowall Ltd.,
United Kingdom
• Mark Newton, Associate Senior Consultant QA, Eli Lilly &
Co., USA
• Nigel Price, IT Compliance Manager, Crucell
Switzerland, Switzerland
• Michael Rutherford, Consultant – MDU – Business
Systems, Eli Lilly & Co., USA
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Single-Use is evolving fast and there is a call for
standardization. This provides an opportunity for the ISPE
community to discuss their needs with the folks writing the
documents.
• Leader: James Vogel, PE, Founder/Director, The
BioProcess Institute, USA
Single-Use Standardization Update – Interactive Panel
Discussion
• Pietro Perrone, PE, Mobius Single-Use Systems Engineer,
EMD Millipore Corporation, USA
• Christopher Smalley, Director, Engineering, Global
Technical Operations, Merck & Co., Inc., USA
End-to-End Supply Chain Management Track
5-503: CLINICAL SUPPLIES AND THE
INVESTIGATOR SITE: DRIVING A SITECENTRIC ORGANIZATION Room: Liberty A-B (Level 3)
ISPE has been at the leading edge of facilitating a forum
for Investigator Sites to share their experiences during
study execution and the role that clinical supplies play in
patient adherence and retention strategies. While we have
heard forum sites in the past, converting their feedback into
actionable change has been an industry challenge. Several
top leaders and experts within pharma companies are
leading that paradigm shift within the industry.
• Leader: Nicole Pierson, Patient Representative/Advocate
A Patient’s Perspective on Clinical Research
• Robert Pizzie, PhD, Managing Partner, Brizzey LLC, USA
Clinical Supplies and Investigator Site: Driving a Site Centric Organization (Panel Discussion)
• Daniel Crosby, Director, Drug Supply Management, Bristol Myers Squibb, USA
• Michael Ku, PharmD, VP, Global Clinical Supply, Pfizer, Inc.,
USA
• Massimo Eli, PhD, Global Clinical Supply Regional Lead,
MSD Italy SrL/Merck Corp., Italy
13
Monday, 09 November
16.00 – 17.30 EDUCATION SESSIONS
2-215: GLOBAL REGULATORY
TOWN HALL – GENERAL SESSION
Room: Grand A-F (Level 5)
This session will provide delegates and regulators a
forum for open discussion on topics relevant to regulatory
agencies, both domestic and international, and to the
pharmaceutical industry.
• Mark Birse, Group Manager Inspectorate, MHRA,
United Kingdom
• David Churchward, Expert GMDP Inspector, MHRA,
United Kingdom
• Thomas Cosgrove, JD, Director, Office of Manufacturing
Quality, Office of Compliance, FDA/CDER/OC/OMQ, USA
• Richard Friedman, Deputy Director, Science and
Regulatory Policy, FDA/CDER/OC/OMQ, USA
• Sabine Haubenreisser, PhD, EMA-FDA Liason, DHHS/
FDA/OC/OGROP/OIP, USA
• Masatoshi Morisue, Director, GMP Inspections,
Pharmaceuticals and Medical Devices Agency, Japan Tuesday, 10 November
10.45 – 12.15 EDUCATION SESSIONS
Innovation Forum Track
6-603: PART 1 – ROADMAP FOR
21ST CENTURY AND BEYOND; PART
2 - PREVENTING AND GOVERNING
ORPHAN DATA – CRITICAL SUCCESS
FACTORS IN ENSURING DATA
INTEGRITY
Room: Grand I (Level 5)
This presentation will cover the attached meaning to
data and data quality, and discuss how to combine
data into information and find, explore and interpret that
information.
Part 1: How does your company manage inconsistent
business processes and information flows across process
development and manufacturing? There are various
business and technical drivers to have a new information
14
ISPE Annual Meeting 2015
management strategy in place, such as cost and time,
isolated systems in place, need to reduce dependence
on the individuals and others. This presentation will
talk about the attach meaning to the data, data quality,
combine data into information and how to find, explore
and interpret information.
Part 2: Ensuring data integrity provides for a
comprehensive summary of the data integrity topic, as
well as providing innovative ideas related to data integrity
pitfalls and their associated solutions including “orphan
data,” i.e. data that remains input source computerized
systems and/or is overwritten or deleted never making it
to the Quality System for review.
• Leader: Alfred Penfold, BSc MBA, Director, Global
Engineering, Pfizer, Inc., United Kingdom
Welcome and Introductory Remarks:
Where Will We Find Innovation?
• Rebecca Brewer, Strategic Practice Lead, Quality
Executive Partners Inc., USA
Preventing and Governing Orphan Data – Critical
Success Factors in Ensuring Data Integrity
• Anil Rattan, PhD, Associate Director, Shire HGT, USA
IT Roadmap for 21st Century and Beyond
Facilities and Equipment Track
1-104: IMPLEMENTING SINGLE-USE
TECHNOLOGY FOR BIOMANUFACTURING
– A WORKSHOP ON IMPLEMENTATION
Room: Grand G (Level 5)
This one-day workshop will mix short presentation
lectures, class discussions and group exercises to
provide attendees the chance to use current ISPE
Baseline Guides, Good Practice Guides and recent PE
articles to develop solutions to often-realized issues
within the Industry; when should Single-Use Systems be
implemented?
• Leader: Jeffery Odum, CPIP, SME, Director of
Operations, Biotech Lead, IPS - Integrated Project
Services, Inc., USA
Implementing Single-Use Technology for Biomanufacturing
– A Workshop on Implementation
• David Estape, PhD, Technology Manager Life
Sciences, M+W Process Industries, Germany
• Mark Witcher, PhD, Senior Consultant, IPS, USA
Education Sessions
1-112: CRITICAL UTILITIES
MAINTENANCE PROGRAM AND
OPERATIONAL OPTIMIZATION
Room: Independence I-III (Level 3)
Within the Pharmaceutical Industry, little guidance
is available for pharmaceutical engineers to develop
maintenance activities and frequencies and to optimize
operations for critical utility systems. In addition,
modifying maintenance activities and/or frequencies or
system parameters can be difficult for a pharmaceutical
engineer to implement. This results in pharmaceutical
companies having higher expenditures on maintenance
and operational activities than they need to.
• Leader: Brian Severson, Project Manager, Kroeschell
Engineering Company, USA
Critical Utilities Maintenance Program and Operational
Optimization
• Robert Augustine, Associate Senior Consultant
Engineer, Eli Lilly & Co., USA
• Roderick Freeman, Manager, Validation and
Calibration and Global Process Owner – Process
Validation, Beckman Coulter, USA
• Andre Gill, PE, Engineer, USA
• Gregory Littrell, Maintenance Manager, Johnson
& Johnson, USA
1-116: CROSS-CONTAMINATION:
DEDICATION, SEGREGATION OR
OTHER? Room: Grand K (Level 5)
This session discusses managing the crosscontamination risks of multi-product production, and the
application of risk methods.
• Leader: George Petroka, CIH, CSP, Principal, IES
Engineers, USA
• Glenn Lawrence, PE, CPIP, Managing Consultant,
Tunnell Consulting, USA
Cross-Contamination: Dedication, Segregation or Other?
• Tyler Griffin, CSP, Qualitest Pharmaceuticals, USA
• Samuel Halaby, Senior Director Global Strategy, IPS, USA
• Robert Sussman, PhD, Managing Principal, SafeBridge
Consultants, Inc., USA
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Regulatory Compliance and Quality Systems Track
2-204: PROCESS CAPABILITY FOR
CONTINUOUS IMPROVEMENT: PART 1
Room: Liberty C (Level 3)
New guidances provide incentives for the pharma sector to
adopt process capability and control approaches that have
delivered substantial business benefits in other industries.
These concepts and tools may require adaptation to be
effective in the regulated pharmaceutical manufacturing
environment. Case studies and a new framework to guide
implementation of the tools to achieve maximum return on
investment will be presented.
• Leader: Philippe Cini, PhD, Group Vice President,
Operational & Process Improvement, Tunnell
Consulting, USA
Leader: Daniel Peng, PhD, Quality Assessment Lead,
FDA/CDER/OPQ/OPF, USA
Achieve Six Sigma in Pharmaceutical Manufacturing –
Power of Process Capability Indices
• Michael Pulido, Director Technical Services, Par
Pharmaceutical, USA
Generic Manufacturer’s Perspective on How to Use Process
Capability
• Lawrence Yu, PhD, Deputy Director, FDA/CDER/OPQ,
USA
Product Quality, Quality Metrics, Process Capability, and
Performance Excellence
• Arne Zilian, PhD, Global Head Systems & Standards,
Novartis Pharma AG, Switzerland
ISPE Process Capability Maturity Model
2-207: ADOPTION OF QUALITY
RISK MANAGEMENT PRINCIPLES
IN BREAKTHROUGH THERAPY
Room: Grand L (Level 5)
• Leader: Eric Thostesen, Senior Director, Regulatory
Compliance, Janssen Pharmaceuticals, Inc., USA
• Mariah Deguara-Pagan, Pfizer, Inc., USA
Adoption of QRM Principles in Breakthrough Therapy
• Sarah Pope Miksinski, PhD, Director (Acting),
Office of New Drug Products, FDA/CDER/OPQ/ONDP,
USA
Successfully Moving Forward with IND and NDA
Submissions for Breakthrough Drugs
15
Product Development and Production Systems Track
3-304: SUCCESSFUL PRODUCT
LAUNCHES Room: Grand H (Level 5)
Successful product launches are important to the
end users who are in the need of these life-saving
drugs. This round table discussion also includes
major construction, utilities, equipment and packaging
companies’ representatives who must be involved
with the scale-up of the manufacturing and packaging
facilities. These drug manufacturing companies will need
to fulfill the global demand for treating outbreak diseases
such as Ebola, Swine Flu, and other unknown diseases.
• William Brydges, Principal, Brydges Consulting, USA
• Paul D’Eramo, VP Pharma Regulatory Compliance,
Johnson & Johnson, USA
• Gabriel Foong, President, Unbound-Consulting, USA
•T
homas Golden, Senior Validation Engineer,
Unbound-Consulting, USA
• George Sillup, PhD, Associate Professor of
Pharmaceutical and Healthcare Marketing, St. Joseph’s
University, USA
• Andrew Skibo, Head of Global Biologics Operations &
Global Engineering, MedImmune/AstraZeneca, USA
Information Systems Track
4-404: SPECIALIZED eCLINICAL
SOLUTIONS FOR CLINICAL TRIAL
PROCESSES Room: Grand J (Level 5)
The rapid advance of technology has allowed the
application of manifold technical solutions in support of
clinical trial processes. While such technologies present
opportunities for an increase in efficiency and compliance
for sponsors and sites; the risks associated with their deployment and use must also be considered.
• Leader: Oliver Herrmann, Principal Consultant,
Q-FINITY Quality Management, Germany
• Leader: Eric Staib, Executive Director of Quality
Assurance, PRA Health Sciences, USA
Specialized eClinical Solutions for Clinical Trial Processes
• Phillip Kronstein, MD, Lead Medical Officer, FDA/CDER/
OC/OSI/DCCE/GCPC, USA
Today’s FDA Perspective on the Role of Electronic Source
Data Used in eClinical Systems
16
ISPE Annual Meeting 2015
• Maximilian Stroebe, PhD, Associate Director, Global
Electronic Systems Quality Assurance, Netherlands
Validation and Operation of Statistical Systems
End-to-End Supply Chain Management Track
5-504: CUSTOMS AND BORDER
PROTECTION (CBP) ROUNDTABLE:
HOW TRADE REGULATIONS AND
POLICY INFLUENCE THE SUPPLY
CHAIN Room: Liberty A-B (Level 3)
Distribution of clinical trial supplies is increasing its
complexity and becoming a global business. Trade
regulations and processes are constantly evolving to
eliminate trade barriers, promote economic growth and
enhance public safety. New import/export processes and
regulations bring opportunities and challenges for clinical
supplies international distribution.
• Deborah Mower, Import/Export Regulatory Compliance
Manager, Pfizer, Inc., Inc., USA
New ACE/ITDS “Single Window” is Coming! Is Your FDA
Data Ready?
• Roopal Patel, Sr. Director, Global Trade Compliance,
PAREXEL International, USA
Trade Regulations: Looking Forward
• A nthony Orosz, Branch Chief, Pharmaceutical CEE,
Department of Homeland Security
Easing Import Activities: How the New Centers of
Excellence & Expertise (CEEs) Can Work for You
Tuesday, 10 November
13.30 – 15.00 EDUCATION SESSIONS
Innovation Forum Track
6-607: PART 1 – ASIA-PACIFIC GMP
UPDATE AND OUTLOOK; PART 2 –
INNOVATIVE TECHNOLOGIES IN CHINA:
IMPLEMENTATION CHALLENGES AND
SOLUTIONS
Room: Grand I (Level 5)
Part 1: This presentation describes the various problem
areas relating to GMP in the Asia-Pacific region,
particularly the various GMP problem areas that currently
exist in India and China. The presentation also highlights
the growing influence of PIC/S in Asia-Pacific and
Education Sessions
how this influence will gradually help to improve GMP
standards throughout Asia-Pacific.
Part 2: This presentation addresses how to overcome the
challenges of quality, safety and schedule management
that companies usually face in design and construction
of a large-scale pharmaceutical facility in China – through
innovative project execution techniques.
• Leader: John Honey, Head of Engineering, Roche
China Introductory Remarks: Is Innovation Important in
a Global Market?
• Thomas Stanway, Director of Built Environment,
AstraZeneca, United Kingdom
Innovative Technologies in China – Implementation
Challenges and Solutions
• Robert Tribe, AP Regulatory Affairs Advisor, ISPE,
Australia
GMP Update and Outlook – Asia-Pacific
Facilities and Equipment Track
1-105: BIOMANUFACTURING: THE
CONVERGENCE OF CONTINUOUS
PROCESSING AND SINGLE-USE
TECHNOLOGY
Room: Grand K (Level 5)
Advanced continuous bioprocessing and single-use
technologies are available for most bioprocessing
applications. Continuous biomanufacturing offers a
solution to the inherent scale limitations of
single-use technology and benefits from the availability of
disposable closed process systems which are ideal for
axenic and aseptic operations. The convergence of these
two technologies shows promise to become a more
flexible and cost-effective cGMP production methodology
for biotherapeutics.
• Leader: David Marks, PE, Principal, DME Engineering,
USA
The Resurgence of Continuous Biomanufacturing: What’s
All the Buzz About?
• Hsu-Feng Ko, Senior Scientist, Janssen R&D
(Johnson & Johnson), USA
Utilization of Fluidized Bed Centrifuge (FBC) for Continuous
Bioprocessing of Both Cell Recovery and Cell-Secreted
Products
CONNECT SHARE FOLLOW #ISPEAM15
•D
avid Krantz, Director Process Engineering, Shire, USA
Use of Single-Use Technology in a Perfusion
Bioreactor Application
• Robert Snow, CPIP, Principal Engineer Biologics
Development, Genzyme Corporation, a Sanofi Company, USA
Chromatography Column Sterilization Needs and Challenges for Continuous Operation
1-113: EFFECTIVE INTEGRATION
OF ENVIRONMENTAL HEALTH
AND SAFETY REQUIREMENTS
INTO PROJECT DESIGN REVIEW
Room: Independence I-III (Level 3)
The EHS aspects of design review are not often
systematically incorporated into projects. Implementing
this effectively reduces regulatory risk and ensures
optimization of the design, improving productivity,
reducing cost and schedule impact from stage
appropriate front-end loading of the design development
process.
• Leader: Ronald Brunelle, Quality Assurance Director,
Amgen, Inc., USA
• Leader: Nicholas Haycocks, Senior QA Specialist,
Amgen, Inc., USA
• Denise Bender, Director, Environmental Health and
Safety, Amgen Inc., USA
• Michael Walling, Co-Director, IN Communication,
France
Integrating Health, Safety and Environmental Issues into
Project Design Review
Regulatory Compliance and Quality Systems Track
2-205: FDA UPDATE FROM THE OFFICE
OF PHARMACEUTICAL QUALITY
Room: Grand H (Level 5)
• Leader: David Doleski, Deputy Director (Acting),
FDA/CDER/OPQ/OPF, USA
Welcome and Introductory Remarks: Office of Process & Facilities Hot Topics
• Robert Iser, Director, FDA/CDER/OPQ/OPF/DPAIII, USA
FDA Integrated Product Evaluation
• Giuseppe Randazzo, MS, Acting Office Director, FDA/
CDER/OPQ/OPRO, USA
Optimizing Information Requests
17
2-206: PROCESS CAPABILITY FOR
CONTINUOUS IMPROVEMENT PART 2
Room: Liberty C (Level 3)
New guidances provide incentives for the pharma sector
to adopt process capability and control approaches
that have delivered substantial business benefits in
other industries. These concepts and tools may require
adaptation to be effective in the regulated pharmaceutical
manufacturing environment. Case studies, and a new
framework to guide implementation of the tools to achieve
maximum return on investment, will be presented.
• Leader: Philippe Cini, PhD, Group Vice President, Operational
& Process Improvement, Tunnell Consulting, USA
• Leader: Daniel Peng, PhD, Quality Assessment Lead,
FDA/CDER/OPQ/OPF, USA
Achieve Six Sigma in Pharmaceutical Manufacturing - Power of Process Capability Indices
•S
au Larry Lee, PhD, Associate Director for Science,
FDA/CDER/OPQ, USA
Regulatory Approach for Emerging Pharmaceutical
Technology
•P
eter Millili, PhD, Principal Engineer, Bristol Myers Squibb,
USA
The Role of Process Capability in Monitoring Product
Quality: Compliance Monitoring Requirements vs.
Self-Audit Continuous Improvement Opportunities
Product Development and Production Systems Track
3-305: NEW DIRECTIONS IN
CONTINUOUS PROCESS FOR mAb
MANUFACTURING Room: Grand L (Level 5)
Continuous processing promises a new year in mAb
manufacturing but has so far not materialized in
production scale. What are the motivators, barriers and
enabling technologies needed to make this happen?
• Leader: Niels Guldager, CPIP, Senior Technology
Partner, Biopharmaceuticals, NNE Pharmaplan A/S,
Denmark
What is Holding the Industry Back from Implementing a
Continuous mAb Bioprocess?
• Suyamburam Sathasivam, General Manager, R&D
Biotechnology, Sun Pharmaceutical Industries
Ltd., India
Continuous Process for mAb Manufacturing
18
ISPE Annual Meeting 2015
3-309: BIOMANUFACTURING FACILITY
CAPACITY IMPROVEMENT USING
PROCESS MODELING
Room: Grand G (Level 5)
With decreased available capacity to support pipelines,
with decreased capital budgets to alleviate capacity
constraints, how can companies maximize their capacity
utilization to avoid massive capital expenditures?
• Leader: Todd Troutman, Associate Director - Project
Management, AstraZeneca, USA
Biomanufacturing Facility Capacity Improvement Using
Process Modeling
• Chad Briggs, Director Manufacturing Technology Innovation, MedImmune
Information Systems Track
4-405: CLINICAL DATA ARCHIVING
AND eTMF MIGRATION CASE STUDY
Room: Grand J (Level 5)
In accordance with GCPs sites sponsors must
appropriately archive and maintain their clinical data.
This has become a challenge despite new technologies
and the use of eTMFs. This session provides guidance,
current industry solutions and a case study to help
ensure the necessary requirements are being met while,
more importantly, maintaining the integrity of relating
information and data critical to a products licensure.
• Leader: Oliver Herrmann, Principal
Consultant, Q-FINITY Quality Management, Germany
• Leader: Eric Staib, Executive Director of Quality
Assurance, PRA Health Sciences, USA
Clinical Data Archiving and eTMF Migration Case Study
• Nicolas Pelletier, PhD, PRA Health Sciences, USA
• Theresa Stokes, PhD, Director, GXP International, USA
Electronic Archives for GXP Retention Periods: Not Your
Backup Tapes!
Special Topics Key:
BIOPHARM
RISK-BASED APPROACHES
CHINA/ASIA-PACIFIC FACILITIES
DATA INTEGRITY
SINGLE-USE TECHNOLOGIES
METRICS
YOUNG PROFESSIONALS FRIENDLY
Education Sessions
process, which directly impacts the time it takes to
deliver new products, such as vaccines, into the market.
End-to-End Supply Chain Management Track
5-505: COUNTERFEIT MEDICINES:
CURRENT STATUS AND TRENDS ON
SERIALIZATION AND TRACK AND
TRACE Room: Liberty A-B (Level 3)
For Pfizer, counterfeit medicines are, first and foremost, a
matter of patient health and safety. Counterfeit medicines
pose a threat to patients because of the conditions under
which they are manufactured, unlicensed, unregulated,
uninspected and often from unsanitary sites.
This presentation is intended to educate pharmaceutical
professionals on current efforts taken by Pfizer to
understand and mitigate counterfeiting activities while
providing broad educational content for the audience.
• Rubie Mages, JD, Director Strategic Planning, Pfizer
Global Security, Pfizer, Inc., USA
Counterfeit Medicines - A Threat to Patient Health and Safety
•L
ars Olsen, Principal Consultant, Global Consulting,
Serialization, NNE Pharmaplan, Denmark
Mario Giampietro, Validation & IT Manager, Nordika Do
Brasil Consultoria Ltda, Brazil
Current Status and Trends on Serialization and Track and Trace
Tuesday, 10 November
16.00 – 17.30 EDUCATION SESSIONS
Innovation Forum Track
6-606: PART 1 – INNOVATIVE PROCESS
FOR EXPEDITIOUS PREPARATION OF
CAPITAL APPROPRIATION PACKAGES
FOR THE BIOPHARM INDUSTRY; PART
2 – A NEW APPROACH TO IMPROVE
MAJOR PHARMACEUTICAL PROJECT
Room: Grand I (Level 5)
CAPITAL EFFICIENCY
Part 1: The industry’s current best practices for the
planning and funding of future manufacturing facilities
is slow and imprecise. Prolonging the decision-making
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Part 2: As blockbuster drugs become less common
and patent cliffs become more common in the
pharmaceutical industry, companies are increasingly
focused on managing resources with greater efficiency,
including capital investments. What are some ways
that capital efficiency can be improved quickly
while maintaining essential schedule/budget/quality
deliverables?
• Leader: Patricia Melton, BSc, MBA, PhD, Managing
Director, Mime Solutions, United Kingdom
Welcome and Introductory Remarks: What Limits
Innovation? Project Risk Tools to Promote Understanding
• Jose Rivera, Project Executive, The Beck Group, USA
Innovative Process for Expeditious: Preparation of Capital
Appropriation Packages
• Brent Pilgrim, Director of Services, The Beck Group,
USA
• Barry Holtz, PhD, Principal, Holtz BioPharma
Consulting, USA
• Ryan Schad, PE, Consultant – Business Operations,
Eli Lilly & Co., USA
A New Approach to Improve Major Pharmaceutical
Project Capital Efficiency
Facilities and Equipment Track
1-106: DECOMMISSIONING
PHARMACEUTICAL EQUIPMENT AND
FACILITIES Room: Grand J (Level 5)
Many sites are closing or being repurposed to meet
changing demand of new products. There are many
ways of managing these changes, and the new ISPE
Good Practice Guide provides must-have guidance
to the approaches allowing development of the most
effective method. This presentation supports the new
guide and give some real life examples of how the
philosophies of the guide have been used.
• Leader: Mark Foss, Central Engineering & Facilities
Director, UK Manufacturing, CooperVision, United
Kingdom
ISPE Good Practice Guide: Decommissioning of
Pharmaceutical Equipment and Facilities
• Martin Emery, Technical Engineering Specialist,
Amgen, Inc., USA
19
1-115: HVAC SUSTAINABILITY
Product Development and Production Systems Track
Room: Independence I-III (Level 3)
• Leader: Norman Goldschmidt, Principal, Genesis
Engineers, Inc., USA
Introduction and Update on ISO-14644
• Leader: Nicholas Haycocks, Senior QA Specialist,
Amgen Inc., USA
•R
obert Bowen, Global Co-chair HVAC + Sustainable
Facilities CoP; UK Affiliate Director, Facilities Integration
Ltd., United Kingdom
HVAC Sustainable Facilities Stream – ISPE Handbook:
Sustainability
•P
eter Gardner, Sustainability Manager, Torcon,
Inc., USA
High Temperature Filters – Current Best Practices
•N
igel Lenegan, Managing Director, Energy & Carbon
Reduction Solutions Ltd., United Kingdom
The Impact of Clean Room Gowning on Room
Performance and ISO for Gowning
•D
an Milholland, Managing Partner, Milholland
& Associates, USA
Unidirectional Air Flow Specification and Testing
Regulatory Compliance and Quality Systems Track
2-214: INTERNATIONAL REGULATORY
UPDATES Room: Grand H (Level 5)
• David Churchward, Expert GMDP Inspector, MHRA,
United Kingdom
Inspection Trends, Data Integrity and Tox Based Facility
Risk Assessments
•L
eader: Sabine Haubenreisser, PhD, EMA-FDA Liason,
DHHS/FDA/OC/OGROP/OIP, USA
• Mark Birse, Group Manager Inspectorate, MHRA, United
Kingdom
PIC/S Perspective
2-211: CASE STUDIES IN SUSPECT
PRODUCT NOTIFICATION REPORTING
Room: Grand Salon C-D (Level 5)
• Leader: Anthony Strange, Global Director Brand
Protection, Johnson & Johnson, USA
Quality Lead Case Study
• Anthony Zook, Director, Product Integrity, Merck & Co.,
Inc., USA
Security Lead Case Study
20
ISPE Annual Meeting 2015
3-306: DEVELOPMENT
WORKFLOWS AND EMERGING
TECHNOLOGIES IN CONTINUOUS
PROCESSING
Room: Grand L (Level 5)
The benefits of continuous processing in small molecule
pharmaceutical manufacturing are well understood but
development and manufacturing functions in companies
are not ideally set up to enable implementation of
continuous processing. This session will highlight some
approaches to accelerate the adoption of continuous
manufacturing processes, discussing investments in
assets and people, organizational changes and workflows
developed to enable exploitation of emerging technologies
in this area.
• Leader: Markus Krumme, Novartis, USA
Leader: Philip Shering, Associate Engineering Director,
AstraZeneca, United Kingdom
Development Workflows and Emerging Technologies in
Continuous Processing
• Alastair Florence, Professor and Director, EPSRC
Centre for Innovative Manufacturing in Continuous
Manufacturing and Crystallisation University of Strathclyde,
United Kingdom
• Anne O’Kearney-McMullan, APS Continuous,
AstraZeneca, United Kingdom
Why and How Should Continuous Processing be Used for
API Manufacture of Pharmaceuticals? (A Chemist’s View…)
• Sonja Sharpe, PhD, Director, Technology
Development Lead, Secondary Manufacturing,
GlaxoSmithKline, USA
Bridging Primary and Secondary in Oral Solid Dose
Manufacturing through API Particle Engineering
3-310: COMMISSIONING AND
QUALIFICATION PROJECT
MANAGEMENT – THE ULTIMATE
CHALLENGE! Room: Liberty C (Level 3)
Commissioning and Qualification activities present unique
challenges from a project management perspective
regardless of the size and scope of the project. The impact
of the C&Q phase of a project can have a significant impact
on not just the project schedule and cost, but also on the
ability of the company to provide quality products to their
patients.
Education Sessions
This presentation will examine the tools available within
the ISPE Good Practice Guide: Project Management
for the Pharmaceutical Industry to better manage these
projects and the associated risks. Additionally, the session
will offer practical examples and advice from industry
professionals that have led recent C&Q projects.
• Leader: Michael Lynam, Director, PM Group, Ireland
• Leader: Andrew Roberts, Project Consultant,
MIME Solutions Ltd., United Kingdom
• Shannon Chesterfield Yonker, Associate
Director, Commercial Manufacturing, Heron
Therapeutics, USA
C&Q Project Management – The Ultimate Challenge!
Information Systems Track
4-403: COMPLIANT-REGULATED
Room: Grand G (Level 5)
MOBILE APPLICATIONS
Today, many of us carry phones in our pockets that are
vastly more powerful computers than those that took the
Apollo astronauts to the moon. These powerful mobile
devices have tremendous potential as platforms for
everything from marketing tools to scientific reference
sources to life-saving medical devices. Life science
companies and regulators have recognized this potential
and are working on approaches to safely and profitably
leverage it.
• Leader: Arthur Perez, PhD, Director, Info Governance-Mgmt
Novartis Pharmaceuticals, USA
Compliant-Regulated Mobile Applications
• Erik Anderson, Senior Manager, Quality Computer
Systems Validation, Johnson & Johnson, USA
Addressing Some of the Pitfalls When Implementing Digital
Assets/Mobile Applications
4-406: THE CHALLENGE OF IT
INFRASTRUCTURE
Room: Grand K (Level 5)
IT Infrastructure Qualification demonstrates control over
network components that are relied upon by the rest of
the enterprise. Typical Infrastructure Qualification presents
many unforeseen challenges which can be overcome by
process efficiencies so the effort only needs to be done
once for each component. Using a risk assessment to
drive this process hones in on area/device configurations
that should be tested and points to procedural controls
that help complete the quality system.
CONNECT SHARE FOLLOW #ISPEAM15
• Leader: Kevin Martin, Senior Vice President, Azzur
Group LLC, USA
The Challenge of IT Infrastructure
• Mark Quinty, Senior IT Technical Consultant, Azzur
Group LLC, USA
• Doug Shaw, CISA, CRISC, Director of CSV & IT
Consulting, Azzur Consulting, USA
End-to-End Supply Chain Management Track
5-506: ROUND TABLE ON
COUNTERFEIT MEDICINES:
REGULATORY CHALLENGES WITH THE
EU (ANNEX 6); METRICS FOR CLINICAL
TRIALS
Room: Liberty A-B (Level 3)
Clinical Trial Materials are obviously important
ingredients that enable successful clinical research;
however, there is no real standardization around a set of
comprehensive metrics for supply chain performance.
Consequently, innovators, contract manufacturers, and
other partners in the supply chain are left to start from
scratch or “reinvent the wheel” when defining what
will be measured to provide indicators of success or
indicators that things may be going wrong.
The EU commission has released a new version of
Clinical Trial Regulation Annex 6, EU GMP Guidance.
This regulation will have a significant impact on how
clinical trials can be performed within the EU.
• Sandra Cook, PhD, President, Cook Consulting, USA
Metrics for Clinical Trials: Task Team Update
• Massimo Eli, Global Clinical Supply Regional Lead,
MSD Italy SrL/Merck Corp., Italy
New EU Regulation 536/2014 on Clinical Trials on
Medicinal Products for Human Use
• Rubie Mages, JD, Director Strategic Planning, Pfizer
Global Security, Pfizer, Inc., USA
• Joseph Buerger, Brand Protection Technology
Manager, Global Product Protection Group, Takeda,
USA
21
Wednesday, 11 November
08.30 – 10.00 EDUCATION SESSIONS
Innovation Forum Track
6-605: ACHIEVING INNOVATION
IN SCIENCE FACILITIES DESIGN —
PROVIDING HIGH-VALUE, INNOVATIVE
DESIGN AND DELIVERY STRATEGIES
WITH FIXED PROJECT CONSTRAINTS
Room: Grand I (Level 5)
We will explore how we, as a profession, can enhance
design and innovation on projects with a fixed schedule,
budgetary requirements and other constraints which
would traditionally diminish creativity and value. Through
a case study of HDR’s recently completed Pirbright
Institute, we will explore how early engagement and
interdisciplinary collaboration can provide “more with
less”.
• Leader: Keith Gibbs, Director of Project Delivery
Innovative Process Solutions, USA
Welcome and Introductory Remarks: What is Innovation?
• David Bendet, Principal, Director of
Science+Technology, HDR Architecture, USA
• Rachel Park, Principal Strategic Planner, HDR Inc., USA
Achieving Innovation in Science Facilities Design: A
Guide to Providing High-Value and Innovative Design
and Delivery Strategies on Projects with Fixed Project
Constraints
Facilities and Equipment Track
1-107: RISK-BASED QUALIFICATION
– 10 YEARS AFTER THE LANDMARK
ISPE WHITE PAPER ON RISK-BASED
QUALIFICATION FOR THE 21ST
CENTURY
Room: Grand J (Level 5)
Ten years after the landmark ISPE white paper on riskbased C&Q was published (2005), companies struggled
to implement the vision. This is due to perceived
regulatory hurdles and the impact of the transition on
legacy quality and engineering systems. The relationship
22
ISPE Annual Meeting 2015
of C&Q to PV is not yet fully understood. Sharing
experiences from pharma companies on the journey to riskbased C&Q will allow members to gain practical insight to
take back to their companies on the transition.
• Leader: Mark Rezac, Director of Compliance, IPS, USA
Risk-Based Qualification – 10 Years After the Landmark
ISPE White Paper on Risk-Based Qualification for the 21st
Century (2005)
• Peter Werner Christensen, CPIP, Process Group
Responsible, Validation and QRM, Denmark
QRM-Based Validation – A Case Study After a Global
Implementation
• Alice Redmond, PhD, Vice President,
Commissioning Agents Inc., Ireland
Benchmarking Science Risk Based Approaches
•G
henet Simpson, Operational Engineering Manager,
GSK Consumer Health, USA
Principles, Hurdles and Lessons
Regulatory Compliance and Quality Systems Track
2-209: QUALITY METRICS – PART 1
Room: Grand H (Level 5)
Part 1 of the Quality Metrics session will provide a summary
of findings and recommendations from the ISPE Quality
Metrics Pilot Program (Wave 1), an update on progress and
next steps for the Pilot Program (Wave 2), a case study on
implementation and utility of standardized quality metrics
– success and challenges; a European regulatory view on
quality metrics.
Moderator: Donna Gulbinski, Senior VP, Global Quality &
EHS, Bristol-Myers Squibb Co., USA
• Mairead Goetz, Head of Compliance, Group
Compliance & Audit, Group Quality Assurance,
Novartis Pharmaceuticals Corporation, USA
ISPE Quality Metrics Initiative: The Journey so Far
• Lorraine McClain, Senior Director, Quality Risk
Management, Teva Pharmaceuticals, USA
Paul Weninger, SVP Quality Operations, Perrigo
Company PLC, USA
ISPE Quality Metrics Program: Wave 2, Metrics and
Definitions
• Betsy Fritschel, Director of Quality & Compliance,
Johnson & Johnson, USA
• Steve Greer, Corporate QA External Engagement Leader,
Procter & Gamble, USA
Implementation of a Standardized Quality Metrics Program,
Examples from Industry
Education Sessions
• Mark Birse, Group Manager Inspectorate, MHRA,
United Kingdom
Quality Metrics: A European Perspective
2-203: APPLYING RISK-BASED
VALIDATION TO MOVE TO AN ASTM
Room: Grand E (Level 5)
E2500
Industry is still unclear as to how to fulfill the requirements
of Stage 2 of the Process Validation guidelines. The
principles of ASTM E-2500 and risk-based validation can
be utilized together to ensure all requirements are fulfilled
while also reducing the effort of duplication of work.
• Leader: Bikash Chatterjee, President and CSO,
Pharmatech Associates, USA
Applying Risk-Based Validation to Move to an ASTM E2500
Program
• Vijay Chiruvolu, Senior Director, USA
• Dilip Joshi, Head of Strategic Manufacturing, Complex
Products, USA
•W
ai Wong, Vice President, Validation, Pharmatech
Associates, USA
Product Development and Production Systems Track
3-307: ADVANCES IN NEXT GENERATION
MANUFACTURING Room: Grand A (Level 5)
Learn how next generation manufacturing can improve
manufacturing, decrease the footprint of the manufacturing
site, reduce environmental impact, simply drug
manufacturing, decrease cost of unit manufacturing,
improve speed to market, improve local manufacturing and
make supplies of drugs more sustainable.
• Leader: Robert Dream, PE, Principal, HDR COMPANY
LLC, USA
Advances in Next Generation Manufacturing
• Robert Bowen, Global Co-Chair HVAC + Sustainable
Facilities CoP; UK Affiliate Director, Facilities Integration
Ltd., United Kingdom
Process Stream – Continuous Processing
CONNECT SHARE FOLLOW #ISPEAM15
3-311: PAT IN RAW MATERIALS: THE USE
OF PAT TOOLS AND METHODOLOGIES
TO DRIVE CONSISTENCY AND
PERFORMANCE THROUGHOUT
THE MANUFACTURING PROCESS
Room: Grand B (Level 5)
Our industry strives for consistency and conformity in the
raw materials used as the basis for product manufacture.
The use of Process Analytical Technologies (PAT) in
the form of instrumentation and modeling provides an
opportunity to detect potential issues with raw materials
and to adjust the process to compensate for any abnormal
conditions before they become quality and compliance
issues.
• Leader: Robert Perks, MSc, CEng, Engineering
Specialist, Baxter Healthcare Corp, USA
PAT in Raw Materials: The Use of PAT Tools and
Methodologies to Drive Consistency and Performance
Throughout the Manufacturing Process
• Myra Coufal, PhD, Principal Scientist, Amgen, Inc.
Predicting a Product Quality Attribute by Incorporating Raw
Material Parameters Using Multivariate Modeling: A Case
Study
• Pamela Docherty, Life Sciences Industry Manager,
Siemens Industry, Inc., USA
Integration of Raw Material Quality Data in the Process
• Stephen Hammond, Senior Director, Pfizer Global
Supply, Pfizer, Inc., USA
Use of PAT Tools to Understand the Behavior of All
Ingredients in a Pharmaceutical Formulation During
Processing
Information Systems Track
4-407: CURRENT STATUS AND
TRENDS ON SERIALIZATION AND TRACK
AND TRACE – PART 1
Room: Grand D (Level 5)
Serialization and Track and Trace for pharmaceutical
drugs and medicines has become a major subject among
the pharma industry and the regulatory agencies in
many countries, mainly due to the increasing counterfeit
occurrences and its high risks to consumers’ and patients’
health. High concerns and consequent commitment from
the government on this subject caused the publication of
many new regulations in the past years – and more are to
come. There is an urgent need to prepare strategies and
to implement actions with challenging deadlines, to cover
23
these new and future requirements, to be in compliance
and to receive the benefits from these regulations.
• Leader: Marcelo De Oliveira, Validation and Consultancy
Manager, NORDIKA, Brazil
• Leader: Christopher Reid, CEO, Integrity Solutions, UK
Current Status and Trends on Serialization and
Track and Trace
• Fatma Taman, General Manager, PharmaVision Sanayi Ve
Ticaret AS, Turkey
Timur Kabadayi, Managing Director, CONVAL Group,
Turkey
Mass Serialization and Track and Trace Implementation
• Eamonn O’Mathuna, Manufacturing Systems
Consultant, Enterprise Systems Partners Ltd., Ireland
Current Status on Serialization and Track and Trace
Legislations in Worldwide Markets
4-409: IMPROVING YOUR
INTERACTIONS WITH CLOUD
PROVIDERS
Room: Grand C (Level 5)
The use and understanding of the “Cloud” continues to
be a significant issue for the pharmaceutical industry and
is an ongoing source of debate between IT departments,
businesses, and regulatory agencies. This session is
designed to help regulated firms that will be engaging
with cloud providers that do not currently understand the
regulated firm’s “language.”
• Leader: Kathleen Gniecko, IT Quality Management
Services Head, F. Hoffmann - La Roche AG, Switzerland
Improving Your Interactions with Cloud Providers
•M
ichael Crowthers, Senior Manager, Life Sciences &
Healthcare Industry, Deloitte & Touche LLP, USA
Establishing SLAs and Internal Controls for PaaS
Solutions
• Heather Ouellette, CISA, CIPP/US, CISSP, Director,
Security & Compliance Customer Success, Salesforce,
United Kingdom
Auditing the Cloud Provider
End-to-End Supply Chain Management Track
5-507: REAL-WORLD EXPERIENCES
WITH e-LABELING; ENGLISH-ONLY
ON PRIMARY PACKS AND e-LABELS;
TRANSCELATE UPDATE ON e-LABELING
Room: Grand F (Level 5)
Part 1: The industry is looking for alternative ways to label
IPs and to reduce the amount of text. Smaller containers
and packages have only reduced the amount of space
available to place required information. New trends in
JIT Labeling/Packaging require English-only or universal
language labels to be used in the most efficient way.
Part 2: The presentation will present a summary of the
ISPE IP CoP Position Paper on e-Labels/English-only on
primary packs. Presentation will provide an overview of
the work the task team has done over the last two years.
This will include an analysis of the supply chain and the
impact of elabel solutions, definition of user requirements,
patients, investigator sites quality aspects, benefit and
challenges for patients and investigator sites.
• Leader: Sascha Sonnenberg, Vice President
Commercial Operations, Marken Ltd., Germany
Position Paper: English-only on Primary Packs and
e-Labels, and Usage of Pictograms as a Universal
Language
• Michael Moorman, Executive Director, Pfizer, Inc., Inc.,
USA
Real World Experiences with e-labeling
• Jodi Smith-Gick, Dir., Clinical Trial Pkg-Logistics, Eli
Lilly & Co., USA
Transcelate Update on e-labeling and Q&A on e-labeling
Special Topics Key:
24
BIOPHARM
DATA INTEGRITY
RISK-BASED APPROACHES
CHINA/ASIA-PACIFIC FACILITIES
METRICS
SINGLE-USE TECHNOLOGIES
ISPE Annual Meeting 2015
YOUNG PROFESSIONALS FRIENDLY
Education Sessions
Wednesday, 11 November
Facilities and Equipment Track
10.30 – 12.00 EDUCATION SESSIONS
1-108: FACING THE CHINA CHALLENGE
– AN INTERACTIVE WORKSHOP ON
CONSTRUCTION PROJECTS IN CHINA
Innovation Forum Track
6-608: PART 1 – RESISTING
TEMPTATION – A UNIQUE
APPROACH TO IMPLEMENTING
NEW PHARMACEUTICAL SYSTEMS;
PART 2 – CASE STUDY: RESOLVING
A LEGACY PRODUCT QUALITY ISSUE
THROUGH APPLICATION OF PROCESS
UNDERSTANDING AND DESIGN OF
EXPERIMENTS Room: Grand I (Level 5)
Part 1: When embarking on the implementation of a new
system, the temptation is to look at the systems available
in the marketplace and pick the so-called “best” one,
while a new approach is to first look internally at your
processes, people, and existing technology to determine
the changes that must occur. The implementation of
a new system is really a change management project,
and must be managed as such, and not as a vendor
selection project. Today, we simply can’t afford to make
a bad choice.
Part 2: A root cause approach using underlying process
mechanisms and DOE can provide quick resolutions to
quality problems while one-factor studies and correlative
analyses fail to do so.
• Leader: Keith Gibbs, Director of Project Delivery,
Innovative Process Solutions, USA
Welcome and Introductory Remarks: Innovation. How Do
You Recognize It?
• Mark Mitchell, Principal Engineer, Pharmatech Associates,
USA
Case Study: Resolving a Legacy Product Quality Issue
Through Application of Process Understanding and
Design of Experiments
• Keith Williams, Founder and Managing Director,
Formpipe, Inc., USA
Resisting Temptation – A Unique Approach to
Implementing New Pharmaceutical Systems
CONNECT SHARE FOLLOW #ISPEAM15
Room: Grand E (Level 5)
This interactive workshop will give participants insight into
the challenges of executing a large-scale pharmaceutical
project in China. The session will introduce and guide
participants through key risk areas using case studies as
examples. By the end of the workshop, participants will
gain a better understanding of the challenges of delivering
projects in China.
• Leader: Alan Osborne, Regional Director Asia-Pacific,
Global Engineering, AstraZeneca, China
• Kwame Agyei-Owusu, Project Engineer, AstraZeneca,
China
• Denton He, Project Manager, AstraZeneca, China
• Martin Teo, Project Director, AstraZeneca, China
Regulatory Compliance and Quality Systems Track
2-210: QUALITY METRICS – PART 2
Room: Grand H (Level 5)
Part 2 of the Quality Metrics session will provide the latest
FDA perspective and ISPE response to the FDA Draft
Guidance Requesting Quality Metrics; Quality Culture
deliverables and future programs.
• Moderator: Donna Gulbinski, Senior VP, Global Quality &
EHS, Bristol-Myers Squibb Co., USA
• Russell Wesdyk, OPS Scientific Coordinator, FDA/
CDER/OPS/IO, USA
Update on FDA Quality Metrics Program
• Nuala Calnan, PhD, Regulatory Science Researcher,
ISPE Quality Culture Team Lead, Dublin Institute of
Technology, Ireland
ISPE Quality Culture Program
Panel Q & A:
• Mark Birse, Group Manager Inspectorate, MHRA,
United Kingdom
• Tara Gooen Bizjak, LCDR, PHS, Senior Science Policy
Advisor, FDA/CDER/OPQ, USA
• Karthik Iyer, Acting Branch Chief, FDA/CDER/OC/OMQ, USA
• Vanya Telpis, Senior Knowledge Expert, McKinsey & Co.
• Russell Wesdyk, OPS Scientific Coordinator, FDA/
CDER/OPS/IO, USA
• Alex Viehmann, Operations Research Analyst, FDA/
CDER/OPS, USA
ISPE Quality Metrics Team
25
2-208: END-TO-END PRODUCT RISK
Room: Grand C (Level 5)
MANAGEMENT
How to manage a complex product pipeline with an
established product portfolio and opportunities to optimize
resources.
• Leader: Robert Kowal, MS, RPh, Director, Risk
Management and Criticality Analysis, Janssen
Pharmaceuticals Inc., USA
Overcoming Challenges in a Global Criticality Analysis
Program
•M
ark Birse, Group Manager Inspectorate, MHRA,
United Kingdom
ICH Q12 and Beyond: An EU Regulatory Perspective
• J üergen Wolfgang, PhD, Senior Director Product
Quality, Janssen Supply Chain, Switzerland
Proactive Product Quality Risk Management – A Lifecycle
Management Approach
Product Development and Production Systems Track
3-308: SINGLE-USE TECHNOLOGY:
THE ADVANCES OF A FLEXIBLE
TECHNOLOGY IN A STRUCTURED
ENVIRONMENT
Room: Grand L (Level 5)
Single-Use Technology continues to expand in the
biopharmaceutical industry. There are issues that surface
during the implementation of the technology that can
derail its smooth implementation. This session provides
a forum for discussion of methods to reduce risk and
streamline implementation of the technology. Presentations
highlighting state-of-the-art methods and ideas will be
presented and discussed.
• Leader: Pietro Perrone, PE, Mobius Single-Use
Sys Eng, EMD Millipore Corporation, USA
Single-Use Technology – The Advances of a Flexible
Technology in a Structured Environment
• Malik Belattar, GMP Bioprocess Single-Use System
Expert, Project Manager, Pharma Biot’Expert, France
How to Make E&L from an Unidentified Risk to a Managed Risk
• Sabrina Restrepo, PhD, Associate Director,
Engineering, Merck & Co., USA
Development of Standard Tool for Risk Assessment
Evaluation Related to Single-Use Technologies
•C
hristopher Smalley, Director, Engineering,
Global Technical Operations, Merck & Co., Inc., USA
• David Wolton, Biopharma Consultant, PM Group, Ireland
26
ISPE Annual Meeting 2015
3-312: ANTIBODY DRUG CONJUGATES
– AN OPPORTUNITY AND A CHALLENGE
Room: Grand K (Level 5)
Antibody drug conjugates require containment practices
similar to those for highly potent molecules but are often
developed by biologics firms where toxicity is not a great
challenge. What are the challenges and how should one
approach these toxicity concerns?
• Leader: Peter Marshall, CEng, MI-ChemE, Principal
Technology Engineer, United Kingdom
Antibody Drug Conjugates – An Opportunity and a
Challenge
• Brent Altemose, PhD, CIH, CSP, Principal Industrial
Hygienist, SafeBridge Consultants, Inc., USA
Safe Handling of Antibody Drug Conjugates
• Scott Miller, PhD, Head of Special Projects, CarbogenAmcis AG, Switzerland
• Torsten Belger, Technical Manager, Prosys Containment,
Ireland
Rigid Isolator for a New Antibody Drug Conjugate (ADC)
Cleanroom Laboratory for Highly Potent Compounds
•E
rica Dahl, PhD, DABT, Senior Toxicologist, SafeBridge
Consultants, Inc., USA
Toxicology of ADC Components
3-313: DRUG SHORTAGES PREVENTION
PLAN – BEST PRACTICES AND CASE
STUDIES FOR DEVELOPING THIRD
PARTY API SUPPLIER PARTNERSHIPS
Room: Grand J (Level 5)
The trend in the pharmaceutical industry is towards a supply
chain that leverages an external network for supply of the
API. A successful partnership between the owner and the
contract manufacturer will minimize disruptions to the supply
chain that could potentially lead to drug shortages.
• Leader: Sarah Mancini, Senior Manager, API Technology
Lead, Zoetis, USA
Drug Shortages Prevention Plan – Best Practices and Case
Studies for Developing Third Party API Supplier Partnerships
• Robert Duguid, PhD, Research Fellow, AMRI, USA
Best Practices and Case Studies for Developing Third Party
API Supplier Partnerships: A CRO Perspective
• Ruben Torres, Senior Manager, Pfizer, Inc., USA
Education Sessions
Information Systems Track
4-408: CURRENT STATUS AND TRENDS
ON SERIALIZATION AND TRACK AND
TRACE - PART 2
Room: Grand D (Level 5)
• Leader: Marcelo De Oliveira, Validation and
Consultancy Manager, NORDIKA, Brazil
Leader: Christopher Reid, CEO, Integrity
Solutions, United Kingdom
Current Status and Trends on Serialization and
Track and Trace
• David DeJean, Vice President, Center of Excellence,
SYSTECH International, USA
Case Study - Integrated Serialization and Track and Trace
• Dirk Rodgers, Consultant, SYSTECH International, USA
The Business Process of Serialization and Track and Trace
End-to-End Supply Chain Management Track
5-508: EARLY ACCESS TO
INVESTIGATIONAL MEDICINES – AN
OVERVIEW OF THE INCREASING
TOPICAL ENVIRONMENT, REGULATORY
EVOLUTIONS AND THE PRACTICALITIES
OF PROVIDING EARLY ACCESS TO
INNOVATIVE NEW MEDICINES ON A
GLOBAL BASIS Room: Grand F (Level 5)
Companies developing medicines addressing a high
degree of unmet needs are facing a growing number
of requests from patients and physicians for access to
medicines outside of the clinical development program.
Regulations and legislation in this area is constantly
evolving, no more so than in the US where “right to try”
bill is currently sitting in the House of Representatives.
This presentation will build on the 2014 Concept Paper to
provide an update on recent regulatory changes.
• Leader: Mark Corbett, Managing Director, Clinigen
Group, United Kingdom
Early Access to Investigational Medicines – An Overview of
the Increasing Topical Environment, Regulatory Evolutions
and the Practicalities of Providing Early Access to Innovative
New Medicines on a Global Basis
• Michelle Foust, PharmD, Director of Supply Chain
Strategy, ALMAC, USA
Global Clinical Introduction
CONNECT SHARE FOLLOW #ISPEAM15
Launching at this
Year’s Annual Meeting!
Be the First to See it, Discuss it, and Use it!
ISPE Drug Shortage
Assessment and
Prevention Tool
Take Drug Shortages Prevention
from Theory to Practice
Easy-To-Use Tool for Self-Assessment
and Continual Improvement
Increase Supply Reliability
The tool is designed to help industry mitigate supply
chain problems, prevent negative impacts of shortages
on patients, and identify gaps in manufacturing
production and quality systems.
Download your copy at:
www.ISPE.org/2015AnnualMeetingHandouts
Monday, 9 November, 10.45 – 12.15
Business Continuity Planning for the Prevention
of Drug Shortages: Introducing the ISPE Drug
Shortage Assessment and Prevention Tool
27
Solutions that evolve along with you
Change isn’t the only constant
The life sciences industry zigs. Life sciences organizations have to zag. Through it all,
Deloitte will be there with them. The challenge of converting breakthroughs into market
success has never been more complex. Our clients can rely on us to help them hone
their approaches with broad, integrated solutions that anticipate change, incorporate
new requirements, and transcend borders.
As used in this document, “Deloitte” means Deloitte LLP and its subsidiaries. Please see www.deloitte.com/us/about for a detailed description
of the legal structure of Deloitte LLP and its subsidiaries. Certain services may not be available to attest clients under the rules and regulations
of public accounting.
Copyright © 2015 Deloitte Development LLC. All rights reserved.
Member of Deloitte Touche Tohmatsu Limited
FRESH THINKING, BETTER OUTCOMES
• Chemicals/Manufacturing/Controls
(CMC)
THE PHARMATECH DIFFERENCE
• Analytical Methods and Validation
Staffed by industry experts, Pharmatech Associates provides consulting
and services to the regulated life science industry. Pharmatech’s services
cover four spheres of technical expertise that are necessary throughout
the complete product development lifecycle: Product and Process
Development, Compliance, Regulatory, and Validation. Pharmatech
advises clients that range in size from startups to large multi-national
corporations on projects in Asia, Europe and North America from its
headquarters in the San Francisco Bay Area.
• Tech Transfer, Scale Up,
Trouble-shooting
• Quality Management Systems
• Pre-Approval Preparation
& Readiness
• Acquisition/Partnering Due Diligence
• Quality Risk Management
• Commissioning&Qualification
• Compliance Remediation
• Operational Excellence
Compliance Through Science ®
P: 1.510.732.0177 F: 1.510.732.1992 Toll Free: 1.877.787.0177
contact@pharmatechassociates.com | www.pharmatechassociates.com
ACPE Accreditation
END-TO-END SUPPLY CHAIN TRACK
Day 1: Monday, 9 November 2015
09.00 – 15.00
Session Leader: Michelle Foust, PharmD, Director of
Supply Chain Strategy, USA
CPE Credit Available: 3.00 credit hours
Needs Assessment:
Clinical trials are imperative to answer scientific questions
and patients are a key component of these trials. The
pharmaceutical industry is taking an increased notice
on the design and delivery of clinical trials and IMPs
(Investigational Medicinal Products) to ensure patientfriendly clinical supplies and to improve the overall
experience and compliance of patient volunteers.
Feedback from industry surveys indicate that change
is needed. The evolution of lean practices within the
development of IMPs has not been so kind to the
patients and to the investigational sites. The demand
for standardization and flexibility in clinical trial materials
is often in conflict with patient-friendly and often trends
toward patient-unfriendly. Statistically validated insights
from such surveys drive the hypothesis for patient-centric
design and actionable business initiatives to improve
clinical trials.
These presentations will provide insights into how to
leverage this survey data to gain insights in improving
relationships between patients and the pharma industry
and how it can be employed by both to create patientcentric design for future clinical trials.
At the conclusion of this knowledge-based presentation,
participants should be able to:
• Discuss practices which can be employed to improve
patient and site experiences with IMPs
• Identify different methodologies used to capture patient
feedback on their perceptions of IMPs
• Discuss how to make informed decisions related to
design of future study materials and clinical supply
chains that could lead to improved clinical studies
• Review methods for designing a better trial experience
THE PATIENT INITIATIVE: PATIENT
PERCEPTIONS OF INVESTIGATIONAL
MEDICINAL PRODUCTS (IMPS)
09.00 – 09.30 (0.50 CE)
Esther Sadler-Williams
The Patient Initiatives: Results from the New Survey
Objectives: At the conclusion of this presentation,
participants will be able to:
1. U
nderstand differing methodologies used to get
patient feedback on their perceptions of IMP
2. U
nderstand the impact of key patient differentiators
(demographics such as age, global location, study
type, etc.) on patient experiences, enabling clinical
30
ISPE Annual Meeting 2015
and clinical supply teams to determine when
adjustments are needed to ensure protocol
compliance
3. Be able to make informed decisions related to design
of future study materials and clinical supply chains
that could lead to improved patient compliance as
well as more efficient and effective studies
REAL-WORLD APPLICATIONS FROM
TAKEDA ON PATIENT SURVEY
RESULTS
09.30 – 10.00 (0.50 CE)
Peter Marschel/Beth Gardner
Objectives: At the conclusion of this presentation,
participants will be able to:
1. L
earn approaches used to leverage ISPE data set to
improve patient experience in clinical studies
2. G
ain insights to improve relationships with both
patients and investigators
3. Identify underlying trends to drive practical patient
experience focus business initiatives
PATIENT-UNFRIENDLY TO PATIENTFRIENDLY, COMPLIANCE IN CT AND
ORPHAN DRUGS
10.45 – 11.45 (1.0 CE)
Kristen DeVito
Turning the Page from Patient-Unfriendly to PatientFriendly
Objectives: At the conclusion of this presentation,
participants will be able to:
1. Identify specific patient and clinical site feedback on
design and delivery of Investigational Supplies
2. R
ecognize content and resources developed as
a result of collaboration of the ISPE Investigational
Products Community of Practice
3. Learn practices which can be employed to improve
patient and site experience with their Investigational
Product Supply
4. G
ain knowledge of future strategies and innovations
which may further expand the patient-centric focus of
the IP supply chain
SITE-CENTRIC ORGANIZATIONS
14.00 – 15.00 (1.0 CE)
Rob Pizzie
Clinical Supplies and Investigator Site: Driving a SiteCentric Organization (Round Table)
Objectives: At the conclusion of this presentation,
participants will be able to:
1. G
ain insight into how organizations are converting site
feedback into innovative changes to clinical supply
chains and the organizational and study benefits by
doing so
2. U
nderstand how to overcome organizational hurdles
in the implementation of clinical supply chain
enhancements
3. Engage in an open Q&A discussion with industry
leading experts to better understand opportunities
for clinical supply chain improvements and how
to influence organizational changes through metric
capture and analysis
Day 2: Tuesday, 10 November 2015
13.30 – 17.30
Session Leader: Rubie Mages
CPE Credit Available: 2.25 credit hours
Needs Assessment:
In February 2004, the FDA issued a report on
‘Combating Counterfeit Drugs’, which has triggered
significant interest and activity in the mass serialization
of pharmaceutical products. In that report the FDA
recommended a combination of track and trace and
product authentication technology to secure the
pharmaceutical supply chain. The report specifically
states that the adoption and common use of reliable
track and trace technology is feasible and would help
secure the integrity of the drug supply chain.
Clinical trial materials are obviously important
ingredients that enable successful clinical research,
however, there is no real standardization around a set of
comprehensive metrics for supply chain performance.
Consequently, innovators, contract manufacturers, and
other partners in the supply chain are left to start from
scratch or “reinvent the wheel” when defining what
will be measured to provide indicators of success or
indicators that things may be going wrong.
At the conclusion of this knowledge-based
presentation, participants should be able to:
• Discuss general vision and overview of regulatory
requirements and the progress of the track and trace
implementation around the world
• Identify the threat counterfeit medicines present to
patient health and safety
• Outline the rationale for developing metrics and how
they are calculated
COUNTERFEIT MEDICINES
Objectives: At the conclusion of this presentation,
participants will be able to:
1. R
eview the threat counterfeit medicines present to
patient health and safety
2. D
iscuss Pfizer’s efforts to mitigate threats through
proactive investigations and explore technologies
to make it more difficult for counterfeiters to copy
projects
3. Identify the differences between counterfeit and
authentic Pfizer medicines
CURRENT STATUS AND TRENDS ON
SERIALIZATION AND TRACK AND TRACE
14.15 – 14.45 (0.50 CE)
Mario Brenga Giampietro/Lars Olsen
Objectives: At the conclusion of this presentation,
participants will be able to:
1. Identify the status and Trends on Serialization and Track and Trace
2. R
eview regulatory requirements in different countries
and regions
3. Discuss progress of track and trace implementation
around the world
METRICS FOR CLINICAL TRIALS AND
EU REGULATORY UPDATE
At the conclusion of this knowledge-based
presentation, participants should be able to:
• Define how to harmonize the procedure for the
assessment of applications for clinical trials
• Discuss how simplified reporting procedures which
will spare sponsors from submitting broadly identical
information separately to various bodies
• Define how to increase transparency for metrics for
clinical trials and their outcomes
NEW EU REGULATION 536-2014
ON CLINICAL TRIALS ON MEDICINE
PRODUCTS FOR HUMAN USE
16.30 – 17.00 (0.50 CE)
Massimo Eli
Objectives: At the conclusion of this presentation,
participants will be able to:
1. List aspects of new EU Regulation 536-2014
2. Report out new definitions and new labeling requirements for EU Regulation 536-2014
3. Discuss methods for addressing challenges in EU
Regulation 536-2014
13.30 – 14.15 (0.75 CE)
Rubie Mages
Counterfeit Medicines – A Threat to Patient Health and Safety
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31
ACPE Accreditation
END-TO-END SUPPLY CHAIN TRACK
METRICS FOR CLINICAL TRIALS
17.00 – 17.30 (0.50 CE)
Sandy Cook
Objectives: At the conclusion of this presentation,
participants will be able to:
1. Classify why metrics are developed
2. Select methods for calculating metrics
3. Identify Benchmark data on world class for each metric defined
Day 3: Wednesday 11 November 2015
8.30 – 11.00
Session Leader: Michelle Foust
CPE Credit Available: 2.0 hrs
Needs Assessment:
Conventional labeling techniques for clinical trial supplies
have many disadvantages when compared to electronic
label technology, the e-Labels Initiative is expected to
improve label usage for patients, streamline labeling
approaches at sites and create opportunities to decrease
timelines in the investigational supply chain resulting in cost
efficiencies for sponsors. The initiative will also engage
health authorities and collaborate with other industry
groups. TransCelerate’s Regulatory Council is currently
working with global regulatory executives from various
member companies to confirm the stakeholder landscape
and engagement plans.
At the conclusion of this knowledge-based presentation,
participants should be able to:
• Recognize what e-labeling is and how it can be employed in the clinical trial landscape
• Discuss how to stay engaged if their parent company is participating
• Recognize that e-Labels is the foundation to optimize additional processes and systems at the clinic and for clinical supplies management
REAL WORLD EXPERIENCES WITH
e-LABELING
08.30 – 09.00 (0.50 CE)
Michael Moorman
Objectives: At the conclusion of this presentation,
participants will be able to:
1. Define what e-labeling is and how it can be employed in the clinical trial landscape
2. Relate to real-life experiences from Pfizer and identify what approaches may help others succeed
3. Indicate practical challenges associated with the use of e-labels in the clinical trial landscape
32
ISPE Annual Meeting 2015
POSITION PAPER: ENGLISH-ONLY
ON PRIMARY PACKS AND e-LABELS
AND USAGE OF PICTOGRAMS AS A
UNIVERSAL LANGUAGE
09.00 – 09.30 (0.50 CE)
Sascha Sonnenberg
Objectives: At the conclusion of this presentation,
participants will be able to:
1. Recognize why the usage of pictograms is beneficial
2. Express what the pictograms stand for
3. Identify how to implement the usage of pictograms in their own clinical trials
TRANSCELERATE UPDATE ON
e-LABELING AND Q&A ON e-LABELING
09.30 – 10.00 (0.50 CE)
Jodi Smith-Gick
Objectives: At the conclusion of this presentation,
participants will be able to:
1.Define what are e-Labels
2.Recognize the work TransCelerate is doing to make e-Labels a global reality and how to get engaged
3.Recognize that e-Labels are the foundation to optimize additional processes and systems at the clinic and for clinical supplies management.
EARLY ACCESS TO INVESTIGATIONAL
MEDICINES
10.30 – 11.00 (0.50 CE)
Mark Corbett
Objectives: At the conclusion of this presentation,
participants will be able to:
1. List recent developments in the area of early access, particularly those that have occurred since the 2014 ISPE Concept paper
2. Name the reasons behind the recent environmental changes and the impact this could potentially have on pharma and biotech
3. Describe the key considerations important in the operational implementation of access programs
ACCREDITATION STATEMENT
Attendance at this day and a half course earns
attendees 7.25 ACPE credits. The University
of Florida, College of Pharmacy is accredited by the
Accreditation Council for Pharmacy Education as a
provider of continuing pharmacy education.
Training Information
MONDAY, 9 NOVEMBER – TUESDAY, 10 NOVEMBER
A GAMP® Approach to Data Integrity, Electronic
Records and Signatures and Operation of GxP
Computerized Systems (T50) — New Course!
Room: 411-412 (Level 4)
Instructor: Sion Wyn, Director, Conformity Ltd.
objectives using the complimentary copy of the ISPE PQLI®
Guide Series: Part 1 – Product Realization using Quality by
Design (QbD): Concepts and Principles and Part 2 – Product
Realization using Quality by Design (QbD): Illustrative
Example.
Practical Application of Technology Transfer (T19)
Room: 414-415 (Level 4)
Data integrity is currently one of the highest cited areas
in regulatory observations, and a topic of great interest
within the industry and for regulatory agencies that are
re-evaluating industry guidance and their enforcement
strategies. This course will cover data integrity, electronic
records and signatures, and the compliant operation of
GxP Computerized Systems to provide the tools and
techniques to implement proper controls for data, and
ensure the integrity and validity of information throughout
the data lifecycle. Immediately apply the course learning
objectives with a complimentary bound copy of the
GAMP® 5: A Risk-Based Approach to Compliant GxP
Computerized Systems Guide and an individual download
of the GAMP Good Practice Guide: A Risk-Based
Approach to Compliant Electronic Records and Signatures.
Turning QbD into a Practical Reality (T43)
Room: 408-409 (Level 4)
Instructor: Tara Scherder, Managing Director, Arlenda
This interactive course uses group exercises to
provide examples of how products and processes
can be developed using QbD with an emphasis on
the considerations for implementing these processes
in manufacturing. Topics include: understanding the
principles of a science and risk-based approach; product
and process understanding and patient requirements;
implications of relevant ICH, EMA, ASTM E2500, and FDA
Guidelines; QRM tools (FMEA, risk ranking); applying FMEA
to Control Strategy selection; the relationship between
PQS and GMP and how they link to Control Strategy;
considerations when implementing a control strategy
derived from enhanced QbD approaches; and opportunities
for continual improvement arising from application of
statistical techniques. Immediately apply the course learning
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Instructor: Bruce Davis, Principal, Global Consulting
Technology Transfer (TT) includes knowledge transfer,
science and risk-based principles including ICH Q8, Q9,
Q10, Q11 and efficient processes to meet evolving business
needs. As the industry continues to experience changes,
technology transfer for active pharmaceutical ingredients
(APIs), finished dosage forms and analytical methods
between development and manufacturing sites and
contract manufacturing organizations (CMOs) have become
increasingly important. This course identifies criteria for
successful TT and provides ‘how to’ examples which can
be individually tailored depending on the type and scope
of transfer. It takes into account current industry challenges
and real-world examples as tools for industry professionals
and regulators to use when conducting and evaluating TT
activities. Immediately apply the course learning objectives
using the complimentary copy of the ISPE Good Practice
Guide: Technology Transfer (Second Edition).
Training course registration includes course materials,
break and lunches. Hotel accommodations, hotel fees
and a la carte events are separate from registration fees.
Registration is confirmed only when payment is received.
Annual Meeting registration does not include training
courses.
ISPE CEUs will be sent via email within four weeks of the
event and are based on verification of attendance as well
as receipt of a completed course evaluation.
Training Course Materials are not available for download
and we are not able to ship items for Delegates. Please
contact the hotel business center for shipping assistance.
33
Exhibit Hall
The 2015 ISPE Annual Meeting features an extensive Exhibit Hall with
more than 200 companies offering advanced technologies and services
that will help you solve your most challenging problems and achieve
a competitive edge! Don’t miss the opportunity to visit the exhibits
and network with leading providers of advanced solutions, from clean
room equipment and facility engineering to packaging materials and
compliance and validation services. See the Exhibitor Directory section
of this Event Guide for exhibitor listings and locations.
Exhibit Hall Schedule
Sunday, 8 November 17.00 – 19.00
Visit identified Exhibit Hall Giveaway Sponsors’
Table Top Exhibits to have your entry card
stamped. Drop your completed card into the
drawing tumbler located in the Exhibit Hall for
a chance to win one of several prizes including
a Surface Pro 3 Tablet, Apple Watch, Samsung
Galaxy Note or Sony Video Camera! You must
be present to win and only registered Education
or Training Attendees are eligible.
*Exhibit Hall Giveaway drawings will be
conducted during the afternoon breaks
on Monday, 9 November and Tuesday,
10 November.
34
ISPE Annual Meeting 2015
Welcome Reception
17.00 – 19.00
Monday, 9 November
09.30 – 18.30
Morning Break
10.00 – 10.45
Lunch
12.15 – 13.30
Afternoon Break
15.00 – 16.00*
Mix and Mingle Reception 17.30 – 18.30
Tuesday, 10 November 09.30 – 16.00
Morning Break
10.00 – 10.45
Lunch 12.15 – 13.30
Afternoon Break
15.00 – 16.00*
ENTRANCE
ON
Exhibit Hall Giveaways
Exhibitor Directory
A&B Process Systems
ABEC
201 S. Wisconsin Ave.; PO Box
AUTOMATION ENGINEERING
FABRICATION INSTALLATION
Stratford, WI 54484 USA
Tel: +1-715-687-4332
Fax: +1-715-687-3225
www.abprocess.com
Contact: Nick McCauley
nmccauley@abprocess.com
A&B Process Systems is a proven leader in the design,
fabrication, automation, testing and installation of high
quality stainless steel process skids/super skids, tanks,
auxiliary equipment and piping systems.
3998 Schelden Circle
Bethlehem, PA 18017 USA
Tel: +1-610-861-4666
Fax: +1-610-861-2636
www.abec.com
Contact: Brady Cole
bcole@abec.com
Since 1974, ABEC has been a leader in delivering
integrated process solutions for manufacturing in the
biopharmaceutical industry. Many of today’s leading
antibody, vaccine, and recombinant protein therapies are
manufactured by processes and equipment engineered,
manufactured, installed and serviced by ABEC.
Table #109
tu
tu
AAF International
(American Air Filter)
Table #82
PO Box 35690
Louisville, KY 40232-5690 USA
Tel: +1-888-223-2003
Fax: +1-888-223-6500
www.aafintl.com
Contact: Caroline Pantone
cpantone@aafintl.com
AAF (AmericanAirFilter) is a world leader in air filtration
products and gas-phase filtration and is recognized
globally for quality, expertise, and innovation.
AAF understands the critical requirements of the
pharmaceutical industry.
Table #123
ACIC/TEMA SINERGIE
Table #88
81 Sinclair Boulevard
Brantford, Ontario N3S 7X6 Canada
Tel: +519-751-3668
Fax: +519-751-1378
www.acic.com
Contact: Eduardo Andrade
machinery@acic.com
For 30+ years Tema Sinergie has been focusing on
designing & manufacturing radio protection systems
& healthcare equipment. With our partner ACIC, a fullpharmaceutical company, we bring to North America
barrier isolators & automatic glove test systems
in compliance with GMP regulations for sterile &
hazardous preparations.
Adents
Table #16
116 Village Blvd., Suite 200
Princeton, NJ 08540 USA
Tel: +1-609-452-0414
Fax: +1-609-520-1702
www.adents.com/en
Contact: Jim Cummings
aforconi@adents.com
Adents is a software company offering the most
personalized way to connect brands to their markets with
unique product identification. Brands use our software
to comply with regulations on product traceability and to
adapt to fast changing markets.
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35
AdvanceTEC, L.L.C.
AIRPLAN USA
1300 Business Center Drive
Richmond, VA 23236 USA
Tel: +1-804-378-1550
Fax: +1-804-378-4055
www.advancetecllc.com
Contact: Bryan Phelan
bryanp@advancetecllc.com
AdvanceTEC is a cleanroom design/build general
contractor specializing in the integration of cGMP
compliant finishes and systems. Clients find our inhouse technical expertise, 3D BIM coordination, open
market business practices, and field execution to be top
reasons for repeat client projects. Give us a try.
15807 Biscayne Blvd., Unit 211
North Miami Beach, FL 33160 USA
Tel: +1-321-888-2888
www.airplan-usa.com
Contact: Valentí Sellarés
info@airplan-usa.com
AIRPLAN delivers complete production facilities
for Life-Science Industries offering comprehensive
consulting services, conceptual and functional design
solutions, precise engineering and full development and
execution of customized cleanroom infrastructures and
processing equipment.
Table #85
AES Clean Technology, Inc.
Table #119
422 Stump Road
Montgomeryville, PA 18936 USA
Tel: +1-215-393-6810
Fax: +1-215-393-6819
www.aesclean.com
Contact: Ralph Melfi
jclark@aesclean.com
Specializes in the D/B of cGMP Cleanrooms and is the
exclusive US manufacturer of the AES Pharma Wall and
Walkable Ceiling System. Products feature laminar flow
modules, weigh/dispense booths, air showers, modular
cleanrooms, turnkey HVAC systems, HEPA filters,
cleanroom lights, pass thrus and other integrated services.
Agilent Technologies Inc.
Table #97
5301 Stevens Creek Blvd
Santa Clara, CA 95051 USA
Tel: +1-408-345-8886
Fax: +1-408-345-8474
www.agilent.com/chem
Contact: Jennifer Link
jennifer.link@agilent.com
Agilent is a leading provider of sample preparation,
chromatography, mass spectrometry, elemental analysis,
molecular spectroscopy, and laboratory information
systems as well as support services, columns and
consumAbles. Learn more www.agilent.com
36
ISPE Annual Meeting 2015
Table #134
AIV Solutions
Table #31
20,000 Horizon Way, Suite 100
Mount Laurel, NJ 08054 USA
Tel: +1-856-234-2806
Fax: +1-856-234-4542
www.aivsolutions.com
Contact: Arch Chawla
achawla@aivsolutions.com
We are an independent Control System Integrator
who provides automation consulting, control system
evaluation and selection, control system design,
configuration, commissioning and validation services for
the Pharmaceutical and Biotech customers. We are well
versed in cGMPs and GAMP.
Alconox, Inc.
Table #44
30 Glenn Street, Suite 309
White Plains, NY 10603 USA
Tel: +1-914-948-4040
Fax: +1-914-948-4088
www.Alconox.com
Contact: Jeff Phillips
Jphillips@alconox.com
Alconox, Inc. is dedicated to being the leader in critical
cleaning detergents. We manufacture quality detergents
made in the United States and provide outstanding
technical service to the scientists and engineers with
precision cleaning needs.
Allegheny Bradford, Top
Line Process, Allegheny
Surface Technology
Table #72
P.O. Box 200
Bradford, Pennsylvania 16701 USA
Tel: +1-814-362-2590
Fax: +1-814-362-4674
www.alleghenybradford.com
Contact: Chuck Ridenour, Tim Zetts
cridenour@alleghenybradford.com
Experts in stainless steel process equipment, solutions,
and specialty services. Our equipment includes: modular
process systems, tanks, filter housings, heat exchangers,
valves, pumps, tubing, and fittings. Our in-house and On-site
services include electropolishing, passivation, and pickling.
Almac Group
Table #140
25 Fretz Road
Souderton, PA 18964 USA
Tel: +1-215-660-8500
Fax: +1-215-660-8501
www.almacgroup.com
Contact: Richard Segiel
richard.segiel@almacgroup.com
The Almac Group is an established contract
development/manufacturing organization providing
integrated services globally within the pharma and
biotech sectors. Services include biomarker discovery
and development, API manufacture, formulation
development, clinical trial supply, IRT technology, and
commercial manufacture.
Amec Foster Wheeler
Table #15
1635 Market St. Suite 1500
Philadelphia, PA 19103 USA
Tel: +1-215-656-2961
Fax: +1-215-561-4444
www.amecfw.com
Contact: Megan Marshall
megan.marshall@amecfw.com
Amec Foster Wheeler designs, delivers and maintains
strategic and complex assets for its customers. With
over 40,000 employees in 54 countries, the company
operates across the whole of the pharmaceutical and
biotech industry – from bulk processing through fill/finish &
packaging.
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American Technologies, Inc.
Table #197
210 Baywood Avenue
Orange, CA 92865 USA
Tel: 800-400-9353
Fax: 714-283-995
www.atirestoration.com
Contact: Michael Herd
mike.herd@ATIRestoration.com
ATI is a national leader in restoration, environmental
remediation and reconstruction. Services include
24-hour emergency response; water, fire and smoke
damage; lead/asbestos removal and mold remediation;
biohazard cleanup; contents cleaning; restoration; packouts and reconstruction.
Applied Control
Engineering, Inc.
Table #154
700 Creek View Road
Newark, DE 19711 USA
Tel: 302.738.8800
Fax: 302.738.7381
www.ace-net.com
Contact: Ian P. Burns, P.E., CFSP
sales@ace-net.com
Since 1991, ACE has helped manufacturing and
engineering professionals in every aspect of process
control and systems integration. From platform selection
and design to startup and validation, as an independent
systems integrator, ACE implements the right solution on
time and on budget.
Apprentice Field Suite
Table #65
APPRENTICE
155 Palisade Avenue, Suite 3
Field Suite
Jersey City, NJ 07306 USA
Tel: +1-201-417-5028
Fax: +1-973-646-8717
www.apprenticefs.com
Contact: Gary Pignata
gary@apprenticefs.com
Augmented Reality/VR hands free technology, a
mobility & collaboration tool that uses Smart Glasses.
Designed specifically for pharma mfg with Enhanced
Telepresence/Remote Troubleshooting. Reduce
downtime/mistakes, improve quality/safety. Come test
the “Best New Pharma Mfg. Product, Worldwide 2015”
SMART GLASSES FOR BIOPHARMA MANUFACTURING
AR/VR Mobility Solution
37
Aqua-Chem
Table #99
3001 E. Gov. John Sevier Hwy.
Knoxville, TN 37914 USA
Tel: +1-865-544-2065
Fax: +1-865-525-5203
www.aqua-chem.com
Contact: Daniel Lineberger
dlineberger@aqua-chem.com
Aqua-Chem is the leader in providing Global Water
Solutions. We develop innovative and comprehensive
water solutions for the Military, Pharmaceutical, Oil and
Gas, Industrials, Bottled Water, Commercial Marine, and
Micro-utilities markets. We build water processing systems
with custom engineering and cutting edge technology
AST
Table #118
4110 South Washington Street
Tacoma, WA 98409 USA
Tel: +1-253-475-0200
Fax: +1-253-472-7164
www.ast-inc.com
Contact: Joe Glover
jglover@ast-inc.com
Established in 1965, AST specializes in providing
machinery that solves complex aseptic manufacturing
challenges. As a recognized leader in providing
adaptive aseptic manufacturing solutions, we deliver
the most flexible fill-finish systems for processing
pre-sterilized containers including vials, syringes and
cartridges.
ASTRO PAK CORPORATION
Asahi/America, Inc.
Booth #210
655 Andover Street
Lawrence, Massachusetts 01843 USA
Tel: +1-800-343-3618
Fax: +1-800-426-7058
www.asahi-america.com
Contact: Adam Herbert
asahi@asahi-america.com
Asahi/America is a leading manufacturer of corrosion
resistant thermoplastic fluid handling products including
valves, actuators, pipe and fittings. The company
maintains an extensive custom fabrication department
and provides on-site consultation, supervision and training
where required.
ASEPCO
Table #78
355 Pioneer Way
Mountain View, CA 94041 USA
Tel: +1-650-691-9500
Fax: +1-650-691-9600
www.asepco.com
Contact: Steve Joy
info@asepco.com
ASEPCO specializes in the design and manufacture
of high purity aseptic valves and magnetic mixers for
the biopharmaceutical industry. They are designed for
use in the most demanding high-purity fluid streams
including media preparation, fermentation, harvest,
separation, refining and purification.
38
ISPE Annual Meeting 2015
Table #180
106 Skyline Drive
South Plainfield, NJ 07080 USA
Tel: +1-908-566-1246
Fax: +1-949-270-0849
www.astropak.com
Contact: Carolyn Morgan
cmorgan@astropak.com
Astro Pak is a global leader of high purity cleaning and
passivation technology. Our services leverage decades
of experience to deliver the most effective chemistries
and techniques, resulting in increased equipment
longevity, reduced corrosion-related downtime and
regulatory compliance.
Atlantium
Table #69
11 Hamelacha STreet
Har Tuv Industrial Park, Israel 99100
Tel: +972-54-308-9077
Fax: +972-2-992-5005
www.atlantium.com
Contact: Orly Dansky-Greenberg
orlyg@atlantium.com
Chemical-free dechlorination + high-level disinfection
with Hydro-Optic UV. Replaces Activated Carbon, SBS
and other bio-fouling methods. Protects RO membranes
and sensitive equipment from microbial contamination.
Green, cost-effective solution field-proven in leading
global pharma companies.
Automated Control
Concepts, Inc.
Table #24
3535 Route 66
Neptune, NJ 07753 USA
Tel: +1-732-922-6611
Fax: +1-732-922-9611
www.automated-control.com
Contact: Arlene Weichert
aweichert@automated-control.com
ACC provides integration services for PLC controls,
HMI/SCADA, S88 Batch control & reporting,
Historians, KPI Visibility, and EBR. Full project life cycle:
requirements/design/development/validation. ACC also
offers bioStation - a flexible bioreactor control system
scalable from development to pilot to manufacturing.
Automation & Validation
Solutions, Inc. (AVS)
Table #161
725 Skippack Pike, Suite 380
Blue Bell, PA 19422 USA
Tel: +1-215-542-7917
Fax: +1-215-542-7927
www.avs3.com
Contact: Michael Carr
mcarr@avs3.com
We provide Automation, Engineering & Validation
Consulting Services.
CORE COMPETENCIES: Process Control; Information
Management; Validation Solutions; Automation
Validation; Process & Facility Engineering; Serialization;
Laboratory QC; Training Services; Technology Products
Azzur Group
Booth #227
726 Fitzwatertown Road, Suite 6
Willow Grove, PA 19090 USA
Tel: +1-800-726-0331
azzur.com
Contact: Kevin Martin
kevin.martin@azzur.com
We are a partnership of companies, a team of talented
professionals, an alliance of like-minded individuals; all
strategically unified to better serve you. By combining
our varied skill sets and industry expertise, we have
been able to develop a comprehensive service line that
is designed to help your business throughout every step
of the system life cycle. It is with thought, ownership and
innovation that our subject matter experts will get you
what you need from Discovery to Delivery™.
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Bahnson Environmental
Specialties
Table #27
4412 Tryon Road
Raleigh, NC 27606 USA
Tel: +1-919-829-6066
Fax: +1-919-833-9476
www.ESchambers.com
Contact: Steve Ferguson
sferguson@bahnson.com
Controlled Environmental Chamber Manufacturer:
Design, Install, Test, Service and Validate Walk-In
Environmental, Stability, Vaccine, High Capacity -75°C
Cascade Low Temperature Storage and Biorepository
chambers, HEPA Filtered Rooms, Warm Rooms,
Incubators, Cold Rooms & Freezer chambers.
Bausch + Stroebel
Machine Company, Inc.
Table #126
21 Commerce Drive, PO Box 206
North Branford, CT 06471 USA
Tel: 203-484-9933
Fax: 203-484-9939
www.bausch-stroebel.com
Contact: Jim Nadlonek
Jim.Nadlonek@bausch-stroebel.com
Our product range specializes in machines for
pharmaceutical primary packaging, including equipment
for washing, sterilizing/depyrogenating, filling, closing
and labeling. Our systems are designed to comply with
the latest FDA and GMP requirements and are available
for all capacity ranges.
Belimed Infection Control
Table #62
2325 Charleston Regional Parkway
Charleston, SC 29492 USA
Tel: +1-763-694-6153
Fax: +1-843-216-7707
www.belimed.com
Contact: Ken Blankenship
ken.blankenship@belimed.com
Belimed is a Swiss-German manufacturer of GMP
Autoclaves and Parts Washers.
39
BioPharma Systems
BMT-USA, LLC
1365 Landis Drive
North Wales, PA 19454 USA
Tel: +1-888-554-5885
Fax: +1-919-573-9490
www.b-psystems.com
Contact: David Pallister / Mark Walkush
dpallister@b-psystems.com
BioPharma Systems represent the following equipment
suppliers. Esco (Downflow Booths and Isolators),
Bausch Advanced Technologies (Vial, Syringe and
IV filling), PalPharma Materials handling equipment,
PBSC Clean room components, Fedegari Sterilization
solutions and ChargePoint Containment Valves.
14532 169th Dr SE, Ste #142
Monroe, WA 98272 USA
Tel: +1-360-863-2252
Fax: +1-360-863-2366
www.bmtus.com
Contact: Scott Noteboom
scottn@bmtus.com
BMT Sterilizers are custom produced to your exact
specifications and needs. Flexible options allow
selection of the right equipment for each specific
sterilization load, packaging and heat/steam type.
Quality and reliability are built into every industrial-grade
stainless steel unit, with our exacting standards.
Table #110
BIOVIA
Table #181
66 York Street
Jersey City, NJ 07302 USA
Tel: +1-973-805-8600
www.qumas.com
Contact: Gil Lobell
BIOVIA.IE.Connect@3ds.com
QUMAS, now part of BIOVIA from Dassault Systèmes,
is the leader in Regulatory, Quality and Compliance
Management Solutions with over 280 global customer
deployments and two decades of experience helping
companies in highly regulated industries. QUMAS
software is available on Microsoft SharePoint 2010,
Oracle, EMC Documentum, Oracle or SQL.
BioVigilant, a division of
Azbil North America
Booth #217
2005 W. Ruthrauff Road, Ste 151
Tucson, AZ 85704 USA
Tel: +1-520-292-2342
Fax: +1-520-292-2365
www.biovigilant.com
Contact: Jamie Diamond
info@biovigilant.com
BioVigilant Instantaneous Microbial Detection™ systems
provide continuous, real-time results for pharmaceutical
monitoring and trending applications of air and water.
IMD® systems detect particles and determine biological
status…simultaneously. No staining, no reagents, no
growth required.
40
ISPE Annual Meeting 2015
Table #150
Bosch Packaging
Technology
Table #61
8700 Wyoming Ave N
Minneapolis, MN 55444 USA
Tel: +1-763-424-4700
Fax: +1-763-4936776
www.bosch.com
Contact: Bosch Packaging Technology
sales@boschpackaging.com
Bosch provides complete pharmaceutical processing,
packaging and manufacturing solutions including
sterilizers, clean utilities, filling systems, track and trace,
tray loaders, washers, isolators, RABS, inspection
technology, validation, and secondary packaging.
Broadley-James Corporation
Table #168
19 Thomas
Irvine, CA 92618 USA
Tel: +1-949-829-5555
Fax: +1-949-829-5560
www.broadleyjames.com
Contact: Sales & Customer Service Department
mvaughan@broadleyjames.com
Broadley-James is a leading manufacturer of sensors
and process control automation. Our products include
the FermProbe, OxyProbe, and Bionet Bioreactor system.
Burkert Fluid Control
Systems
Booth #225
2915 Whitehall Park Drive, Suite 650
Charlotte, NC 28273 USA
Tel: +1-704-504-4440
Fax: +1-949-223-3198
www.burkert-usa.com
Contact: Ursula Johns
marketing-usa@burkert.com
A global system solution provider in the fluid handling
industry. Process control and automation in the hygienic
and biopharm industry offering: improved automation,
product yield, CIP and steam handling.
BWT Pharma & Biotech
Table #184
45 Francis Street
Leominster, MA 01453 USA
Tel: +1-978-534-4900
www.bwt-pharma.com
Contact: Robert Vecchione
robert.vecchione@bwt-pharma.com
BWT Pharma & Biotech is a global market leader in
the pharmaceutical water purification market. BWT is
a biotech equipment / solution supplier for USP, WFI,
Ozone and distribution Systems. With production
facilities and offices in the USA, Europe & Asia.
Camfil
Table #178
10187 N. 96th Place
Scottsdale, AZ 85258 USA
Tel: +1-480-314-1367
Fax: +1-480-314-1367
www.camfil.com
Contact: Lisa Warner
Lisa.Warner@camfil.com
Camfil is the world’s leading Life Science air filtration
supplier. Our clean air solutions include: custom supply
& exhaust housings, auto-scan systems, unique HEPAs,
energy saving HVAC filters and process dust collection.
Our Life Cycle Cost & Clean Room Design & Energy
Optimization software help optimize filter life & reduce
energy costs.
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Canty
Table #81
6100 Donner Road
Lockport, NY 14094 USA
Tel: +1-716-625-4227
Fax: +1-716-625-4228
www.jmcanty.com
Contact: Tod Canty
sales@jmcanty.com
On-line Imaging based particle size and shape
analysis using the latest in CCD Ethernet camera
technology with Canty fused glass, lighting and in-line
measurement of turbidity, color analysis, and percent
solids. Also, provides particle sizing and crystal size
analysis from nucleation to full growth with 2D image.
Capital Projects and Facility
Service
Table #176
1860 Renaissance Blvd.
Sturtevant, WI 53177 USA
Tel: +1-414-455-0331
www.cpfs.com
Contact: Rick Kramer
rick.kramer@cpfs.com
Providing Information Supply Chain Management.
Delivers verified information with our family of Software
Tools, Methodology, and Staff. Provides relational
database of documents & data traceable to assets.
Companion service/software in project execution and
migration of information to ECM and CMMS.
Catalyst Product
Development Group
Table #17
2920 Fortune Cir W Dr, Suite E
Indianapolis, IN 46241 USA
Tel: +1-866-275-2757
Fax: +1-317-396-9906
www.catalystpdg.com
Contact: Terrence Bergin
tbergin@catalystpdg.com
Ingenuity, speed, and collaboration; that’s how we
cultivate vital intellectual property. With over 15
years of experience in industrial design, engineering,
prototyping, and manufacturing – we are the experts
at bringing products to life. Discover your market
potential with integrated solutions from Catalyst Product
Development Group.
41
CE&IC, Inc.
Chemglass Life Sciences
2 Terri Lane
Burlington, NJ 08016 USA
Tel: 609-387-1700
Fax: 609-387-9322
www.ceicinc.com
Contact: Scot Shultz
sshultz@ceicinc.com
CE&IC is a full service engineering firm focused
on serving the pharmaceutical and biotechnology
industries. CE&IC has complete in-house capabilities for
cGMP process and facility design. We assist our clients
in delivering their projects from planning through design,
procurement, construction support, and qualification.
3800 N. Mill Road
Vineland, NJ 08360 USA
Tel: +1-800-843-1794
Fax: +1-800-922-4361
www.cglifesciences.com
Contact: Melanie Coslop
melanie@cglifesciences.com
For over 60 years, Chemglass has manufactured the
highest quality laboratory glassware and equipment. We
fabricate standard glassware items and components
and have the capability to produce the most complex
glass apparatus, intricate electronic equipment and
customized machined components.
Table #38
CGMP Validation, LLC
ChemTreat
10314 Shawnee Mission Drive
Shawnee, KS 66203 USA
Tel: +1-816-305-4626
www.cgmpvalidation.com
Contact: Jesse Gillikin
jesse.gillikin@cgmpvalidation.com
Contract validation and GMP compliance services.
5640 Cox Road
Glen Allen, VA 23060 USA
Tel: +1-804-935-2000
www.chemtreat.com
Contact: Stacy Freed
stacyf@chemtreat.com
ChemTreat is one of the world’s largest providers of
water treatment products & services. We develop
customized programs with sustainable solutions to
s, minimize expenditures, reduce carbon footprints,
and improve water management programs delivered
through the most experienced sales and service team in
the industry.
Table #177
Chase Doors
Table #30
10021 Commerce Park Drive
Cincinnati, OH 45246 USA
Tel: +1-800-543-4455
Fax: +1-800-626-5684
www.chasedoors.com
Contact: Mike Hegner
mhegner@chasedoors.com
With over 100 years in the Industrial door market, Chase
Doors has developed the most comprehensive line
of doors for Pharmaceutical manufacturing facilities
including Sliding Process Room Doors, Sliding Fire
Door Systems, Traffic Doors, Corrosion Resistant Door
Systems and Fiberglass Door Systems.
42
Booth #201
ISPE Annual Meeting 2015
Table #29
Cleanseal Door Systems - ASI
Table #163
5848 N. 95th Ct.
Milwaukee, WI 53225 USA
Tel: +1-800-558-7068
Fax: +1-414-464-9863
cinfo@cleansealdoors.com
Contact: Eric Westfall
cinfo@cleansealdoors.com
Cleanseal manufactures a comprehensive line of
swinging, sliding, roll-up, fire rated and custom doors for
controlled environments. With styles designed to meet
requirements ranging from GMP to Class 1, Cleanseal
provides complete door systems includes your choice
of panel, hardware, frame and interlocking designs.
Clear-Vu Lighting
Table #170
1150 Motor Parkway
Central Islip, NY 11722 USA
Tel: +1-516-333-8880
Fax: +1-516-333-7695
www.clearvulighting.com
Contact: Daniel Lax
dlax@clear-vu.com
Clear-Vu Lighting is the designer and manufacturer
of cleanLED™, LED Lighting Fixtures for Controlled
Environments – clean rooms, containment areas and
surgical suites. All luminaires will be NSF P442 listed,
IP66 rated, NSF2 listed, Class I, Division 2 listed and
DLC qualified. Production of the cleanLED Series will
begin January, 2016.
ClorDiSys Solutions, Inc
Table #106
PO Box 549
Lebanon, NJ 08833 USA
Tel: +1-908-236-4100
Fax: +1-908-236-2222
www.clordisys.com
Contact: Kevin Lorcheim
kevinlorcheim@clordisys.com
Clordisys Solutions, Inc is a worldwide leader in
decontamination and sterilization, using chlorine
dioxide gas, the safest and most effective method of
decontamination available today. Clordisys performs
turnkey services and sells portable equipment for the
decontamination of any area or application.
Clinigen CTS (Clinical Trial
Services)
Cockram Construction
Three Crescent Drive
Philadelphia, PA 19112 USA
Tel: +1-215-789-9504
www.clinigengroup.com
Contact: Andrea Chopek
andrea.chopek@clinigengroup.com
Clinigen CTS (Clinical Trial Services) focuses on the
supply of commercial drugs (comparators, rescue
meds, standard-of-care therapies, co-meds, etc.),
ancillaries, medical devices, Direct-to-Site (D2S), and
Demand-Driven Labeling & Distribution™ (DDLD)
services for clinical trials
8175 Creekside Drive, Suite 260
Portage, MI 49024 USA
Tel: +1-269-321-5068
Fax: +1-269-321-5069
www.cockram.com
Contact: Todd Jarson
todd.jarson@cockram.com
Cockram Construction is a CM with operations in
Australia, China, India and USA. We specialize in the
Pharma-Bio industry with a full range of construction
services. Ask us about our management of the
procurement and construction of AstraZeneca’s 2015
FOYA category winning manufacturing project.
Table #89
Clintrak Clinical Labeling, LLC
Table #153
2800 Veterans Highway
Bohemia, NY 11716 USA
Tel: +1-631-467-3900
Fax: +1-631-467-4977
www.clintrak.com
Contact: Kevin Shea
kevin.shea@thermofisher.com
Take labels off the critical path. Clinical Labels, Booklet
Labels, Single/Multi-panel Labels, Translation and
Regulatory Services, Variable Print, Label Design,
Automated Inspection, Randomization, Patient
Focused, Consultative Project Management, Innovative,
Shortest Cycle Times, Error-Free Work.
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Table #130
COMECER
Table #171
Via Maestri Del Lavoro 90
Castelbolognese, Ravenna 48014 Italy
Tel: +390546656375
Fax: +390546656353
www.comecer.com
Contact: Massimiliano Cesarini
mcesarini@comecer.com
Comecer is a confirmed leader in isolation technology for
pharmaceutical, chemical and food industry applications.
Its product portfolio covers various standard applications,
but also high-quality customised solutions thanks to
specific expertise acquired over the years.
43
Commissioning Agents Inc.
Booth #224
652 N Girls School Rd
Indianapolis, IN 46214-3662 USA
Tel: +1-317-271-6082
Fax: +1-317-271-6097
www.commissioningagents.com
Contact: David Shenberger
jackie.weichman@cagents.com
Utilize our technical and consulting services to improve
the delivery, reliability and efficiency of your equipment,
facilities, and production operations.
Crane ChemPharma &
Energy
Table #159
4444 Cooper Road
Cincinnati, OH 45242 USA
Tel: (717) 572-6175
Fax: (717) 898-7116
www.cranecpe.com
Contact: John Vitti
jvitti@cranecpe.com
Crane ChemPharma & Energy designs and manufactures
a variety of high performance products including a
highly engineered valve portfolio, aseptic and industrial
diaphragm valves, actuation, sight glasses, lined pipe,
fittings and hoses, and air operated diaphragm and
peristaltic pumps. Visit us a www.cranecpe.com.
CRB
Booth #220
1255 Crescent Green, Suite 350
Cary, NC 27518 USA
Tel: +1-919-852-5431
Fax: +1-919-852-5454
crbusa.com
Contact: Lisa Kerner
lisa.kerner@crbusa.com
CRB is a global service provider of engineers,
architects, constructors and consultants driven to
deliver the right solutions to life science and advanced
technology clients. Founded in 1984, we have grown to
a team of more than 800 passionate professionals in 14
offices throughout the country.
44
ISPE Annual Meeting 2015
Critical Process Systems
Group
Table #70 & 71
480 Hercules Drive
Colchester, VT 05446 USA
Tel: +1-802-488-5860
Fax: +1-802-655-8804
www.cpsgrp.com
Contact: Steven Cheung
steven.cheung@cpsgrp.com
Critical Process Systems Group (CPS) is a group of
manufacturing and design companies providing innovative
product solutions to the semiconductor, life science,
chemical processing, industrial gas and other industries.
We can offer broad turnkey solutions or targeted niche
products depending on our customer’s needs.
Dagard Cleanroom
Table #141
Dagard USA corp. c/o Pramex International
1251 Avenue of the Americas, 3rd floor
New York, NY 10020 USA
Tel: +1-609-233-9541
Fax: +33 (0) 472 713 764
www.dagard.com
Contact: Frédéric Faiz
ffaiz@dagard.com
Dagard Cleanroom is one of the largest designer and
manufacturer of pre-engineered modular systems
in the cleanroom industry. We specialize and sell
our first class GMP products to Pharmaceutical/
Biotech plants, BSL containment labs, Medical Device
Manufacturers, Hospitals, Nutraceuticals, Universities
and Nanotechnologies.
Destaco - Central
Research Laboratories
Table #196
691 Squirrel Rd, Ste 250
Auburn Hills, MI 48326 USA
Tel: 248-836-6700
Fax: 248-836-6740
www.destaco.com
Contact: Steve Chunglo
marketing@destaco.com
DESTACO - Central Research Laboratories (CRL)
manufactures manipulation & transfer equipment
and remote handling equipment, which allow human
operators to safely perform dexterous maneuvers in
hazardous or sterile environments. Products include:
Transfer Port Systems, Telemanipulators, Gloveport
Systems, and Waste Drum Transfer Systems.
Booth #222
.........
..
Box 1019
New Caney, TX 77357 USA
Tel: +1-281-354-4419
Fax: +1-281-354-4529
www.emctx.com
Contact: Frank McCrady
fmccrady@emctx.com
EMCID is a political subdivision of the state of Texas
responsible for promoting economic/community
development. Our industrial park has sites available
for business expansion opportunities. Our available
work force and low infrastructure and energy costs are
attractive for expansion needs.
.....
...
..
..
7540 Windsor Drive, Suite 311
Allentown, PA 18195 USA
Tel: +1-610-366-1744
Fax: +1-610-366-1784
DMEforLife.com
Contact: Mark Matson
mmatson@dmealliance.com
DME provides engineering solutions for the
biotechnology, pharmaceutical, medical device, science
& technology, food & beverage, & chemical process
industries. Services include Advanced Technology
Facility Design, MEP Engineering, Process Engineering,
Operations Improvement, & Consulting Services.
East Montgomery County
Improvement District
.........
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..
Booth #212
..........
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DME
Dober Chemical Corp.
Table #107
11230 Katherine’s Crossing
Woodridge, IL 60517 USA
Tel: +1-630-410-7300
Fax: +1-630-410-7444
www.dobergroup.com
Contact: Dan Dobrez
chematic@dobergroup.com
Dober is a leading provider of formulated detergents for
the removal of products, coatings and residues from
processing equipment. Dober’s Chematic® formulated
detergents offer innovative and effective cleaning
solutions for tough to clean polymer and color coatings,
pharmaceutical residues, biotech and blood fractionation.
Eagle Stainless
Endress+Hauser
Table #98
2350 Endress Place
Greenwood, IN 46143 USA
Tel: (650) 388-0918
Fax: (317) 535-2171
www.us.endress.com
Contact: Ravi Shankar
ravi.shankar@us.endress.com
Endress+Hauser is one of the largest instrument
manufacturers in the United States’ industrial
automation industry – specializing in automation
solutions for the Chemical, Food & Beverage, Oil &
Gas, Water and Wastewater, Life Sciences, Power and
Energy, Primaries, and Pulp and Paper Industries.
Table #146
816 Nina Way
Warminster, PA 18974 USA
Tel: +1-215-957-9333
Fax: +1-215-957-9330
www.eaglestainless.com
Contact: Charles Lin
clin1@estainless.com
Mirror polished 316L stainless steel stability bottles,
processing/storage/transport vessels and containers for
the pharmaceutical industry.
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45
Eppendorf
Table #80
102 Motor Parkway
Hauppauge, NY 11788 USA
Tel: +1-800-645-3050
Fax: +1-516-334-7506
www.eppendorf.com
Contact: Warren Ang
info@eppendorf.com
Eppendorf products range from general lab equipment to
large industrial fermentors and bioreactors. Our portfolio
includes incubated shakers, ultra-low freezers, and
industrial bioprocess equipment all used in lab settings for
commercial research, academic, forensic, pharmaceutical,
biotechnological as well as chemical and food.
EquipNet
Table #58
5 Dan Road
Canton, MA 02021 USA
Tel: +1-781-821-3482
Fax: +1-617-671-1269
www.equipnet.com
Contact: Sales
sales@equipnet.com
EquipNet is the world’s most comprehensive surplus
asset management company. We are appraisers,
brokers, and auctioneers of lab and manufacturing
equipment.
Evolution Scientific, Inc.
Table #100
4030 Skyron Drive, Unit D
Doylestown, PA 18902 USA
Tel: +1-215-345-4900
Fax: +1-215-345-4978
www.evolutionscientific.com
Contact: Joseph Morwald, President
jmorwald@evolutionscientific.com
Evolution Scientific is a rapidly growing technical service
provider to the pharmaceutical, biotech, medical device
and healthcare industries. Evolution Scientific provides
preventive and corrective maintenance, calibration and
metrology, certification, validation, technical staffing,
consulting, and project management.
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46
ISPE Annual Meeting 2015
Evoqua Water
Technologies LLC
Table #20
181 Thorn Hill Road
Warrendale, PA 15086 USA
Tel: +1-866-926-8420
Fax: +1-719-550-2232
www.evoqua.com
Contact: Mark Schultz
mark.a.schultz@evoqua.com
Evoqua Water Technologies provides all of the
technologies and services to help you meet the
varied requirements of applications such as drug
manufacturing, medical devices, cosmetics, personal
care products, nutraceuticals and others.
Faubel Pharma Services
Corp.
Table #166
3 Third Street, Suite 103
Bordentown, NJ 08505 USA
Tel: +1-908-730-7563
Fax: +1-908-735-9518
www.faubel.de
Contact: Nurdan Citamak
info@faubel-ps.com
As a proven supplier for the pharmaceutical industry,
we pride ourselves on finding the best label for each
product. Comprehensive patient information with all
markings and required texts is our first priority.
Fedegari Technologies, Inc.
Table #26
1228 Bethlehem Pike
Sellersville, PA 18960 USA
Tel: +1-215-453-0400
Fax: +1-215-453-0406
www.fedegari.com
Contact: Massimiliano Passerini
MPA@fedegariusa.com
Fedegari Technologies is responsible for manufacturing
customized machines, and other relevant components,
designed for the bio-pharma and food industries
worldwide. Our expertise lies in the field of sterile and
clean processes (from sterilizers and chemical biodecontamination units, to washer-sterilizers).
Feldmeier Equipment
Fisher Clinical Services
6800 Townline Rd
Syracuse, NY 13211 USA
Tel: +1-315 454 8608
Fax: +1-315 454 3701
www.feldmeier.com
Contact: David Pollock
dpollock@feldmeier.com
Feldmeier Equipment is one of the world’s leading
manufacturers of sanitary alloy vessels for the
Pharmaceutical and Biologic’s markets.
With a size range from 5 to 130,000 Liters we can meet
your exacting requirements for bioreactors, WFI storage,
buffer, media prep and CIP.
3701 Corporate Parkway
Center Valley, PA 18034 USA
Tel: +1-610-391-0800
fisherclinicalservices.com
Contact: Eric Deschamps
chelsey.gosse@thermofisher.com
Everyday, everywhere, Fisher Clinical Services works
to make the clinical trial supply chain simpler and safer.
Purposely built, quality assured, proudly staffed and
keenly aware that a patient is waiting.
Table #41
Fette Compacting
America, Inc.
Table #95
400 Forge Way
Rockaway, NJ 07866 USA
Tel: +1-973-586-8722
Fax: +1-973-586-4050
www.fetteamerica.com
Contact: James Mossop
jmossop@fetteamerica.com
FETTE Compacting America, a leader in precision
tablet press technology which offers a variety of
services to clients in the US, Canada, & PR, including
new and used machine sales, technical assistance,
machine installations, training and seminars, validation,
maintenance, spare parts, and tooling.
Fike
Table #117
704 SW 10th St
Blue Springs, MO 64015 USA
Tel: +1-816-229-3405
Fax: +1-816-229-4615
fike.com
Contact: Daniel Willis
industrialprotection@fike.com
Fike is a global supplier of precision-engineered
solutions for pressure relief, overpressure protection,
fire protection and pressure activation. Since 1945
Fike has designed and built solutions for businesses
worldwide that want peace of mind from experiencing
consequences of serious financial loss or a devastating
disaster. www.fike.com
CONNECT SHARE FOLLOW #ISPEAM15
Table #155
Flad Architects
Table #158
644 Science Drive
Madison, WI 53711 USA
Tel: +1-608-232-1372
Fax: +1-608-238-6727
www.flad.com
Contact: Randy Tuminello
rtuminello@flad.com
Flad Architects has earned a reputation for outstanding
client service and design excellence over its 88year history. Serving the needs of knowledge-based
organizations, Flad specializes in the planning and design
of innovative health, academic, and science facilities.
Fluor
Table #75
100 Fluor Daniel Dr
Greenville, SC 29607 USA
Tel: +1-864-281-4567
www.fluor.com
Contact: Beth Brown, CMP, CTSM
beth.brown@fluor.com
Fluor’s expertise covers the full range of planning,
engineering, procurement, construction and validation
services for new and existing facilities. With our proven
capability to execute projects, Fluor’s Life Sciences is a
reliable solution to minimize risks when delivering new
capital projects of any size - anywhere in the world.
47
Food and Drug
Administration/Center
for Drug Evaluation
and Research/Office of
Compliance
Table #42
10903 New Hampshire Avenue
White Oak Bldg. 51, 5th Floor
Silver Spring, MD 20993 USA
Tel: +1-301-796-3100
Fax: +1-301-847-8747
www.fda.gov/AboutFDA/WorkingatFDA/
GenericDrugUserFeeHiring/default.htm
Contact: Ryan Fitzgibbons
CDEROC_RECRUIT@FDA.HHS.GOV
The Office leads a broad range of programs, including
enforcement of drug approval and labeling requirements,
pharmacy compounding, drug import and export, current
good manufacturing practice, and good laboratory and
clinical practice. Our objective is to assure that human
drugs are safe, effective, and of high quality.
Formpipe
Table #86
331 Newman Springs Road
Building 1, 4th Floor
Red Bank, NJ 07701 USA
Tel: +1-571-220-7645
www.formpipe.com/lifescience
Contact: Steve Griffith
steve.griffith@formpipe.com
The Formpipe Life Science division simplifies complex
process and technology environments to deliver
customers’ quality and compliance goals within their
relevant regulatory framework. This is achieved through
a combination of EQMS Solutions and Consultancy
delivered by experts.
48
ISPE Annual Meeting 2015
Frewitt USA, Inc.
Table #54
249 Homestead Rd., B5U8
Hillsborough, NJ 08844 USA
Tel: +1-908-829-5245
Fax: +1-908-829-5249
www.frewitt-usa.com
Contact: John Ciasulli
info@frewitt-usa.com
Frewitt manufactures robust, high-quality Dry Milling
Equipment including Hammer Mills, Oscillating Mills,
Conical Sieve Mills, Turbo Sifters, Crushers, and Lump
Breakers. Our areas of expertise include solutions for
cGMP/CIP/SIP/Highly Contained systems for low OEL or
low MIE applications.
Garvey Corporation
Table #19
208 S. Route 73
Blue Anchor, NJ 08037 USA
Tel: +1-800-257-8581
Fax: +1-609-561-2328
garvey.com
Contact: Michael Earling
infinity@garvey.com
Garvey has solutions to some of the pharmaceutical
industry’s most challenging issues, such as, tray loading
and unloading, zero pressure accumulation, efficient vial
drying, clean room transfers and inspection stations.
Each product also helps our customers meet today’s
strict FDA requirements.
GEMCO
Table #157
301 Smalley Ave
Middlesex, NJ 08846-2269 USA
Tel: +1-732-752-7900
Fax: +1-732-752-5857
www.okgemco.com
Contact: Gregg Muench
Gmuench@okgemco.com
GEMCO manufactures vacuum tumble blenders
and vacuum tumbler dryers for the pharmaceutical,
chemical, cosmetics, plastics, precious metals and
food industries. GEMCO has been powder processing
experts for more than 100 years.
Gemü Valves
Germfree Laboratories, Inc.
3800 Camp Creek Parkway
Atlanta, GA 30331 USA
Tel: +1-678-553-3400
Fax: +1-404-344-9350
www.gemu.com
Contact: Tom Harvey
hpetty@gemu.com
The Gemü product line includes Diaphragm, Globe,
Angle Seat, PFA and PVDF and Polypropylene valves,
as well as Measurement & Control Systems. Gemü’s
Project Management Division offers important and
valuable services to the customer ensuring that their
project is completed on time and on budget.
11 Aviator Way
Ormond Beach, FL 32174 USA
Tel: +1-386-677-7742
Fax: +1-386-677-0442
www.germfree.com
Contact: Ryan Henry
rhenry@germfree.com
Germfree manufactures modular and mobile facilities
including Cleanrooms, GMP production facilities and
Biocontainment Laboratories. Our turnkey facilities are
customized, scalable and integrated with equipment
and HVAC.
Booth #200
Genesis Engineer
Table #48
1850 N. Gravers Road STE 300
Plymouth Meeting, PA 19462 USA
Tel: +1-610-592-0280
Fax: +1-610-592-0286
www.geieng.com
Contact: Harry Segner
hsegner@geieng.com
Genesis is a full service project delivery firm providing
expert architecture, engineering, construction
management and commissioning services for
technically driven projects. Our “engineering led” focus
sets Genesis apart and enables us to be a leader in the
field of project delivery.
Gerflor
Booth #214
595 Supreme Dr.
Bensenville, IL 60106 USA
Tel: +1-219-819-0955
www.gerflorusa.com
Contact: Mike Carey
mcarey@gerflorusa.com
Gerflor is the third largest flooring manufacture in the
world and the manufacture of Biocontrol the only certified
ISO 4 / GMP Class A cleanroom floor on the market.
CONNECT SHARE FOLLOW #ISPEAM15
Booth #207
Getinge
Table #32
1777 East Henrietta Road
Rochester, NY 14623-3133 USA
Tel: +1-585-737-5550
www.getinge.com
Contact: Michael Mattison
mike.mattison@getinge.com
The Getinge Group is a global provider of equipment,
systems and solutions that contribute to quality
enhancement and cost efficiency. Getinge is a global
provider of both GMP and non-GMP sterilizers,
washers, isolation systems and consumAbles as well as
having the largest direct service support globally.
Getinge La Calhene
Table #187
1325 South Frandsen Avenue
Rush City, MN 55069 USA
Tel: +1-320-358-4713
Fax: +1-320-358-3549
www.getingeusa.com/life-science/products-within/
isolation-technology/dpte-rapid-transfer-port-system/
Contact: Keith Savage
keith.savage@getinge.com
Sterile Transfer, DPTE Alpha Flanges, Sterile Transfer,
DPTE Beta Containers, Sterile Transfer Beta Bags
49
GF Piping Systems
Table #143
9271 Jeronimo Road
Irvine, CA 92618 USA
Tel: +1-714-731-8800
Fax: +1-714-731-6201
www.gfpiping.com
Contact: Paul Galvin
us.ps@georgfischer.com
GF Piping Systems provides high-quality piping
systems, featuring recirculating lab faucet AquaTap and
Fuseal lab waste piping system. Plastic pipe and fittings,
valves, actuators, rotameters, fusion joining technology,
secondary containment, flow monitoring and process
control instrumentation.
Global Vision
Booth #208
15795 Gouin Blvd West
Montreal, QC H9W 2G3 Canada
Tel: +1-514-624-4422
Fax: +1-514-624-7633
www.globalvisioninc.com
Contact: Christine Vannelli
cvannelli@globalvisioninc.com
Global Vision is the world leader in the design and delivery
of Innovative Proofreading Technologies. Our solutions
are widely interoperable and have been integrated into
the packaging workflows of leading consumer packaged
goods companies, printing firms and over 72% of the major
pharmaceutical industry worldwide.
Hamilton Company
Booth #211
4970 Energy Way
Reno, NV 89502 USA
Tel: +1-314-422-0399
Fax: +1-775-858-3028
www.hamiltoncompany.com/products/processanalytics
Contact: John Gleeson
john.gleeson@hamiltoncompany.com
Now Offering Viable Cell Density Measurement with
pH, DO, and OD. Hamilton Company produces process
sensors including pH, optical dissolved oxygen, viable
cell density, optical density, and conductivity. Hamilton
Arc products replace traditional transmitters via
placement of a microprocessor inside the sensor.
HAMO USA
Table #46
500 Office Center Drive, Suite 400
Fort Washington, PA 19034 USA
Tel: +1-855-467-9274
Fax: +1-855-467-2124
www.HAMO.com
Contact: Jorg Dolmetsch
joerg.dolmetsch@amsonic.com
cGMP Pharma Parts Washer
Hargrove Life Sciences
Table #66
Grifols Engineering S.A
Table #25
Pol Levante Calle Can Guasc 2
Parets del Valles 08150 Spain
Tel: 34 93 5710042
Fax: 34 93 5719303
www.grifolsengineering.com
Contact: Oriol Argemi
info.ge@grifols.com
Grifols Engineering offers engineering services,
machinery construction and specific consulting for
biopharmaceutical process. Our expertise focuses on:
Engineering, biotechnological processes. Machinery
and equipment for biopharmaceutical processes,
aseptic and sterile filling and packaging processes.
50
ISPE Annual Meeting 2015
1880 John F. Kennedy Blvd.
Philadelphia, PA 19103 USA
Tel: +1-215-789-9416
www.hargrove-epc.com
Contact: Brian Lipko
blipko@hargrove-epc.com
Hargrove Life Sciences is a team of highly experienced
individuals who have committed their professional
careers to the design and construction of facilities for
the life science industries, including biotechnology,
pharmaceuticals, biofuels, foods, and consumer
products.
Hart Passivation Services, Inc.
IcGXP, Inc.
800 Scenic View Drive
Cumberland, RI 02864 USA
Tel: +1-401-658-2900
Fax: +1-401-658-2901
www.hartcompanies.com
Contact: Donald Cole
dcole@hartcompanies.com
Chemical Cleaning, Passivation, Derouging, Biofilm
Remediation and Sanitizing of High Purity Systems in
the Pharmaceutical and Biotech Industries.
3670 Arizona Street
San Diego, CA 92104 USA
Tel: +1-951-813-0352
Fax: +1-858 408-4219
www.icgxp.com
Contact: Philip Russ
philruss@icgxp.com
IcGXP, Inc. is a full-service consulting firm that provides
expert compliance auditing, risk management and quality
system development services meeting the needs of firms
from product development through commercialization.
We develop programs that are client-specific and resultsoriented to keep your company in compliance.
Table #43
Hyde Engineering +
Consulting
Booth #223
6260 Lookout Rd S#120
Boulder, CO 80301 USA
Tel: +1-303-530-4526
Fax: +1-303-581-0839
www.hyde-ec.com
Contact: Karrie Hogan
karrie.hogan@hyde-ec.com
Hyde Engineering + Consulting is a global leader in
providing pharmaceutical engineering services. This
includes engineering, commissioning/qualification and
cleaning programs (CIP/SIP). Hyde’s CORE Lab is our
centralized lab specializing in cleaning development studies,
analytical services and cleaning cycle optimization.
Hydro Service and
Supplies, Inc.
Table #14
1426 Manning Blvd.
Levittown, PA 19057 USA
Tel: +1-919-544-3744
Fax: +1-19-544-5852
www.hydroservice.com
Contact: Steve Smith
ssmith@hydroservice.com
Water purification systems for the pharmaceutical,
biomedical, microelectronics, food processing, and
educational markets. Applications include Pharma
manufacturing, R&D Labs, building humidification,
softeners and pretreatment, and grey water, rainwater,
and process water treatment systems.
CONNECT SHARE FOLLOW #ISPEAM15
Table #84
IMA Life North America, Inc.
Table #83
2175 Military Road
Tonawanda, NY 14150 USA
Tel: +1-716-695-6354
Fax: +1-716-695-6367
www.ima-pharma.com
Contact: Bruce Houser
bruce.houser@imalife.com
A global supplier of automated processing equipment for
vials, ampoules and syringes. Equipment range includes
rotary and linear washers, depyrogenation tunnels, liquid
and powder fillers, freeze-dryers, loading/unloading
systems, cappers and labelers. We provide solutions for
laboratory, pilot and commercial processing needs.
INcommunication
Table #175
11 rue Louise Colet; Le Mirabeau, Bat. C
Aix en Provence 13090 France
Tel: (33) 442 52 50 40
in-communication.net/en/front_en.htm
Contact: C. Michael Walling
michael.walling@in-communication.net
IN communication develops EHS supports for our
clients. We are showcasing our EHS Design Review
Decisional Aid Software, dEHSign. dEHSign is a
knowledge-based tool that identifies potential hazards
associated with a project, proposes good-practices,
and verifies that they are built into the final project.
51
Integra Companies
Table #164
29 Saratoga Boulevard
Devens, MA 01434 USA
Tel: +1-978-772-6166
Fax: +1-978-772-9466
www.integracompanies.com
Contact: Stephen Peters
SPeters@integracompanies.com
Integra has over 35 years of fluid connection experience
in a variety of industries and applications. For over 20
years, Integra utilized this expertise to set the standard
for hose and tubing assemblies for Biopharmaceutical
applications. Single-use systems only increase the
complexity and number of connections.
International Products
Corporation
Table #47
201 Connecticut Drive
Burlington, NJ 08016 USA
Tel: +1-609-386-8770
Fax: +1-609-386-8438
www.ipcol.com
Contact: Michele Christian
mchristian@ipcol.com
International Products Corporation (IPC) IPC produces
and markets precision cleaners and P-80® temporary
rubber assembly lubricants. The NSF as USDA
A1 Cleaners feature flagship cleaner, Micro-90®
Concentrated Cleaning Solution. The line also includes
biodegradable, alkaline, acidic, neutral, and enzyme
cleaning products.
IPS-Integrated Project
Services, Inc.
Booth #215
721 Arbor Way
Blue Bell, PA 19422 USA
Tel: +1-610-848-3656
Fax: +1-610-828-7383
www.ipsdb.com
Contact: Mark Butler
mbutler@ipsdb.com
IPS-Integrated Project Services, Inc. is a global
provider of technical consulting, design, engineering,
construction, project controls, commissioning
and qualification services for technically complex
development and manufacturing facilities worldwide.
52
ISPE Annual Meeting 2015
JacobsWyper Architects
Table #179
1232 Chancellor Street
Philadelphia, PA 19107 USA
Tel: +1-215-985-0400
www.jacobswyper.com
Contact: Terry Jacobs
haj3@jacobswyper.com
JacobsWyper Architects provides a full range of cGMP
design expertise for many of the largest pharmaceutical
and biotech corporations, from labs to greenfield
and legacy facilities for research and manufacturing,
including OSD liquid, sterile and potent with regulatory
and LEED certified designs.
Jedson Engineering
Table #121
One Centennial Plaza, 705 Central Avenue
Cincinnati, OH 45202 USA
Tel: +1-866-729-3945
Fax: +1-513-965-5998
jedson.com
Contact: Robert Garner
robert.garner@jedson.com
Jedson Engineering is a privately owned, integrated
engineering, procurement, and construction
management (EPCm) company that delivers projects
that improve your profitability.
Jennings Alberts, Inc.
Table #45
PO Box 503
Pipersville, PA 18947-0503 USA
Tel: +1-800-554-7491
Fax: +1-215-766-8212
www.jenningsalberts.com
Contact: Lisa Dugery
lisa.dugery@jenningsalberts.com
Jennings Alberts provides process equipment and
solutions specializing in: heat transfer, point of use
(POU) high purity WFI/USP water coolers, sanitary heat
exchangers, inline mixing and dispersion technology
and vacuum pumps and systems. We represent Alfa
Laval, Busch, Exergy and Quadro.
Kneat Software
Lachman Consultants
Unit 7 Castletroy Business Park
Limerick, V94 KW28 Ireland
Tel: +353 (0) 61 203 826
www.kneat.com
Contact: Eddie Ryan
eddie.ryan@kneat.com
Kneat’s innovative enterprise quality management
software enables global Life Science manufacturers to
transition from a manual labour intensive paper process
to a fully electronic one for their data and document
intensive quality processes such as Validation Lifecycle
Management, Automation Lifecycle management &
much more.
1600 Stewart Ave
Westbury, NY 11590 USA
Tel: +1-516-222-6222
Fax: +1-516-683-1887
www.lachmanconsultants.com
Contact: Linda Evans O’Connor
L.EvansOConnor@lachmanconsultants.com
Lachman Consultants (LCS) provides expert
compliance, regulatory affairs, and technical services
to our global clientele. LCS helps organizations prevent
and resolve compliance problems and develop efficient
and effective strategies for the submission and approval
of drugs and devices.
Table #174
KOSTER American Corp.
Table #18
2585 Aviator Drive
Virginia Beach, VA 23453 USA
Tel: +1-757-425-1206
Fax: +1-757-425-9951
www.kosterusa.com/us_en/
Contact: Ray Hicks
ray@kosterusa.com
Decades of experience make KOSTER a reliable partner
on the construction site. Our high quality product range
includes well-engineered, patented waterproofing products/
systems for every possible problem with pressurized/
non-pressurized water. KOSTER is also a manufacturer of
superior industrial Floor Coatings Systems.
Table #102
Laminar Flow Inc
Booth #216
102 Richard Road
Ivyland, PA 18974 USA
Tel: +1-215-672-0232
Fax: +1-215-672-0768
www.laminarflowinc.com
Contact: Sales Department
info@laminarflowinc.com
Laminar Flow Inc. engineers and manufactures a broad
line of cGMP Clean Room related equipment. From
Laminar Flow Ceiling Systems, to Isolation and RABS,
to Transport Carts, Pass Thrus and Cleanroom stainless
steel furniture. For over 46 years we have provided
quality equipment to the Pharma and Bio Industries.
L.J. Star Inc
Table #40
PO Box 1116
Twinsburg, OH 44087 USA
Tel: +1-330-405-3040
Fax: +1-330-405-3070
www.ljstar.com
Contact: Mike Curnutte
mcurnutte@ljstar.com
L.J. Star is a leading supplier Process Observation
Equipment. A continual focus on the emerging
technologies have allowed us to offer the best in sight
glass and vessel lighting equipment. We understand the
importance of our clients visual inspection needs. We
strive to exceed their expectations.
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Laporte Consultants Corp.
Table #129
1150 1st Avenue Suite 820
King of Prussia, PA 19406 USA
Tel: +1-484-681-5526
www.laporteconsultants.com
Contact: Emilie Pelletier
mjones@laporteconsultants.com
Laporte is a firm of more than 200 employees
specialized in bio-pharmaceutical, food & beverage and
industrial engineering, offering a wide array of services
in the process, building and infrastructure, automation,
packaging and regulatory compliance fields.
53
LEWA-Nikkiso America, Inc.
Table #115
132 Hopping Brook Park
Holliston, MA 01746 USA
Tel: +1-508-429-7403
Fax: +1-508-429-8615
www.lewa-inc.com
Contact: Gary Gaudet
sales@lewa-inc.com
High purity process systems, blending and formulation
skids, pumps, and design-engineer expertise. LEWA
specializes in biopharma purification and dilution
systems, ISO 5 bottling stations and custom fabrication.
LEWA has decades of high purity projects with small,
medium and global biopharma.
Life Cycle Engineering
Booth #219
4360 Corporate Road
Charleston, SC 29405 USA
Tel: +1-843-744-7110
Fax: +1-843-725-1603
www.LCE.com
Contact: Marie Shomo
mshomo@LCE.com
Life Cycle Engineering’s (LCE) Reliability Consulting
Group provides consulting, services and education.
LCE specializes in providing client-specific solutions that
help organizations improve their operating performance.
Life Science Connect
Table #F3
5340 Fryling Road
Erie, PA 16510 USA
Tel: +1-814-897-7700
www.lifescienceconnect.com
Contact: Perry Rearick
info@lifescienceconnect.com
The vision of Life Science Connect is to facilitate
connections and foster collaborations in pharmaceutical
and medical device development to find ways to get
more life-saving and life-improving therapies to market.
Life Science Connect consists of our seven industry
websites, monthly magazine Life Science Leader.
54
ISPE Annual Meeting 2015
Lives International
Corporation
Table #93
Lives International
99 Pine Hill Rd.
LIVES
Nashua, NH 03063 USA
Tel: +1-603-821-1898
Fax: +1-603-821-1888
www.lives-international.com
Contact: Sorin Haias
sorin@lives-international.com
Lives International provides high quality data loggers
and thermal validation systems to the pharmaceutical
industry. We are committed to customer needs and
satisfaction by providing the most up-to-date high-tech
equipment and by offering excellent service.
Lonza
Table #101
8830 Biggs Ford Road
Walkersville, MD 21793 USA
Tel: 301-898-7025
www.lonza.com/moda
Contact: Richard Kelley
richard.kelley@lonza.com
Lonza is the trusted QC testing solution provider for
the pharmaceutical and medical device industries.
Lonza transforms its practical knowledge and
technical expertise to deliver a portfolio of endotoxin
and microbial detection products, and paperless QC
microbiology, software and services that support the
critical needs of regulated manufacturing environments.
M+W Group
Booth #218
201 Fuller Road
Albany, NY 12203 USA
Tel: +1-518-266-3400
Fax: +1-518-266-3458
www.mwgroup.net
Contact: Aimee Robichaud
aimee.robichaud@mwgroup.net
M+W U.S., Inc., owned by M+W Group GmbH based
in Stuttgart (Germany), is a leading global hightech engineering company. Established in 1912, the
company operates in more than 30 countries. M+W
Group manages projects of all dimensions on behalf
of clients from various sectors, including electronics,
chemicals and pharmaceuticals.
M. Davis & Sons, Inc.
Marchesini Group USA
19 Germay Dr
Wilmington, DE 19804 USA
Tel: +1-302-993-3303
Fax: +1-302-998-4984
www.mdavisinc.com
Contact: Mike Kerwien
mike.kerwien@mdavisinc.com
M. Davis specializes in shop fabrication & field
installations of mechanical & sanitary process piping
systems, electrical and controls for the pharmaceutical
industry. Backed by years of experience and an
unwavering commitment to quality, M. Davis will exceed
your expectations.
43 Fairfield Place
West Caldwell, NJ 07006 USA
Tel: +1-973 575 7445
Fax: +1-973 574 4051
www.marchesini.com
Contact: Anna Maria Bellina
sales@marchesiniusa.com
Marchesini Group USA is a leading supplier of
primary and secondary packaging solutions to the
pharmaceutical,and cosmetic industries. Established
in 1992, our North American headquarters supports
the USA, PR, and Canada and is backed by 1,200
Marchesini staff members worldwide. Visit us at www.
marchesini.com
Table #53
Maida Engineering, Inc.
Table #173
1315 Walnut Street, Suite 716
Philadelphia, PA 19107 USA
Tel: +1-215 353 6110
Fax: +1-215 732 2070
www.maidaengineering.com
Contact: Joseph F Maida, PE
jmaida@maidaeng.com
Mechanical, HVAC, Electrical, Piping and Plumbing
Engineering and Design System Integration,
Procurement, Construction Management, Installation
Supervision, PLC Programming, Commissioning & Start
up, Electrical Audits & Studies - Load Flow, Voltage
Drop, Short Circuit, TCC Coordination, Motor Starting,
Harmonic, Reliability & Arc Flash.
Mar Cor Purification
Booth #202
14550 28th Avenue North
Minneapolis, MN 55447 USA
Tel: +1-484-991-0220
Fax: +1-763-592-7771
www.mcpur.com
Contact: Chris Fournier
cfournier@mcpur.com
MCP is a leading provider of complete water treatment
systems & Services. For 40 years & over 1200 installations
providing high-purity water solutions in the Pharma,
Cosmetics, Medical device, food & beverage & dialysis
Markets. MCP provides a line of equipment to meet all of
your USP purified water & Water for injection requirements.
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Booth #206
Mason-Grey Corporation
Table #63
400 Galleria Parkway, Suite 1500
Atlanta, GA 30339 USA
Tel: +1-678-385-7470
Fax: +1-678-385-7471
www.Mason-Grey.com
Contact: Joseph Reini
jreini@mason-grey.com
The Mason-Grey Corporation provides engineering
solutions and services to process industry clients in
energy, metals, plastics, biotech, pharmaceutical, and
other key process markets. Mason-Grey executes
projects and provides services to the Fortune 500 and
mid-tier companies from coast to coast.
MECO
Booth #213
68375 Compass Way East
Mandeville, LA 70471 USA
Tel: +1-860-498-0445
Fax: +1-860-508-1570
www.meco.com
Contact: Mike Wojcik
mwojcik@meco.com
MECO is a leading producer of engineered products for
water purification serving biopharmaceutical customers
throughout the world. From pretreatment to production
to storage and distribution, MECO manufacturers every
piece of capital equipment required by the pharmaceutical
industry. For information, call 800-421-1798.
55
METTLER TOLEDO PCE
Table #165
2640-A White Oak Circle
Aurora, IL 60502 USA
Tel: +1-630-446-7700
Fax: +1-630-446-7710
www.mt.com/pce
Contact: Janice Wortham
janice.wortham@mt.com
Pharmacontrol Electronic GmbH (PCE) is a leading
supplier of inline vision inspection solutions for the
pharmaceutical industry. As a pharmaceutical industry
specialist, PCE provides comprehensive solutions for
Track & Trace, serialization and aggregation tasks and
vision inspection equipment for packaging lines.
Table #136
1020 Monterey Blvd. #2
Hermosa Beach, CA 90254 USA
Tel: +1-310-379-6576
Par Almhem
Contact: Par Almhem
info@modwave.com
Process Solutions: Mixing, Granulation, Drying, Coating;
Lyophilization, Containment, Water Treatment
Powder Handling and Containment: Discharging, Filling,
Conveying, Dosing, Sampling Containment
Modular Solutions: Process Skids, Box-In-Box, Full
Modular Suites and Buildings
MG America, Inc.
MSS Clean Technology Ltd
Table #149
Table #183
31 Kulick Road
Fairfield, NJ 07004 USA
Tel: +1-973-808-8185
Fax: +1-973-808-8421
www.mgamerica.com
Contact: Randy Fraatz
sales@mgamerica.com
MG America, a subsidiary of MG2, Bologna Italy,
is a leading supplier of capsule fillers, capsule/
tablet checkweighers, cartoners, case packers,
thermoformers, pouch fillers, stick pack/sachet
machines, palletizers, track and trace solutions, liquid
and powder fill/finish equipment, syringe assembly
equipment, and more.
St Edmunds House, Margaret Street
York, North Yorkshire YO10 4UX United Kingdom
Tel: 01347 878877
Fax: 01347 878878
www.mss-ct.co.uk
Contact: Mark Crow
mcrow@mss-ct.co.uk
MSS have over 30 yrs. experience in the Design
& Construction of Specialist Clean & Controlled
Environments, including GMP compliance for FDA/
MHRA licensed projects. Continually building on
this impeccable history & knowledge with innovative
thinking. Our proven track record extends internationally
across all cleanroom sectors.
Middough, Inc.
Nicos Group Inc. - Nicomac
Table #112
136 Gaither Drive, Suite 140
Mount Laurel, NJ 08054 USA
Tel: +1-267-250-3705
Fax: +1-856-866-6541
www.middough.com
Contact: Walt Teesdale
walter.teesdale
EPCM facility design for biopharmaceuticals,
biologicals & biotherapeutics; Architectural and
cGMP process throughput analysis; Single Use
Technology implementation; Aseptic fill finish; High
potent compound containment design; Biosafety level
containment design; API expertise; cGMP compliance.
56
ModWave LLC
ISPE Annual Meeting 2015
Booth #203
80 Oak Street
Norwood, NJ 07648 USA
Tel: +1-201-768-9501
Fax: +1-201-768-9504
www.nicosgroup.com
Contact: Claudio Castellarin
sales@nicosgroup.com
Nicos Group Inc. is distributing and servicing in North
America: Nicomac Modular Clean room system
-ICOS washing and sterilizing equipment including
the market leader LST Closure processor. (Washing
Sterilizing Siliconizing). - Moreschi rapid doors for the
Pharmaceutical areas. - Nicomac granulation lines.
NNE Pharmaplan
OPTIMA pharma
3005 Carrington Mill Blvd. Suite 380
Morrisville, NC 27560 USA
Tel: +1-866-810-4073
Fax: +1-510-305-0813
www.nnepharmaplan.com
Contact: Randy Thatcher
rdtc@nnepharmaplan.com
Focused pharma engineering.
NNE Pharmaplan is an international company
specialised in pharma engineering. We help
pharmaceutical companies bring products to market by
providing flexible, compliant and future-proof solutions.
1330 Contract Drive
Green Bay, WI 54304 USA
Tel: +1-920-983-3151
Fax: +1-920-339-2233
www.optima-packaging-group.de
Contact: Mevluet Yilmaz
beate.gurr@optima-usa.com
Optima pharma’s designs and manufactures machinery
in accordance with cGMP requirements for cleaning,
sterilizing, filling, closing and assembly of syringes, vials,
infusion bottles and cartridges for liquid, viscous and
powder products.
Table #226
nora systems, Inc.
Table #68
9 Northeastern Blvd
Salem, NH 03079 USA
Tel: +1-800-332-6672
Fax: +1-603-894-6615
www.nora.com/us
Contact: Tom Hume
industry-us@nora.com
Designed specifically to fit the needs of your laboratory
facility, nora® flooring is naturally bacteriostatic and
fungistatic, ensuring a clean, hygienic space. They are
low-maintenance, making interruptions for cleaning a
rare occurrence.
OMORI MACHINERY CO., LTD
Table #9
2761 Nishikata
Koshigaya-Shi, Saitama 343-0822 Japan
Tel: +81 48 988 2136
Fax: +81 48 961 1333
www.omori.co.jp
Contact: Toshio Okura
okura@omori.co.jp
Omori has been a pioneer in packaging machine
technology for more than half a century.
New products for pharma-market: PTP blister
packaging system and containment capability, highspeed flow wrapper with stacking device, cartoning
device, new flow wrapper with high seal integrity, lower
maintenance etc.
CONNECT SHARE FOLLOW #ISPEAM15
Table #60
Pacific Ozone
Table #21
6160 Egret Court
Benicia, CA 94510 USA
Tel: +1-707-747-9600
Fax: +1-707-747-9209
www.pacificozone.com
Contact: Michelle McHale
sales@pacificozone.com
Pacific Ozone is a leading manufacturer of air-cooled,
corona discharge ozone generators and integrated
ozone contacting systems. In addition to ozone
products, Pacific Ozone offers ozone technology
support and technical services to provide application
specific solutions. Pacific Ozone stands ready to help
you achieve your ozone equipment requirements.
Parker Hannifin
Corporation, Precision
Fluidics Division
Table #13
245 Township Line Road
Hatfield, PA 19440 USA
Tel: +1-215-660-8135
Fax: +1-215-723-2199
www.parker.com/porter
Contact: Allen Hood
allen.hood@parker.com
The Precision Fluidics Division of Parker Hannifin is a
leading supplier of miniature fluidic liquid/gas valves,
diaphragm and syringe pumps and thermal mass flow
measurement solutions integral to the world’s medical
and analytical instrumentation.
57
Parsec Automation Corp
Table #133
180 N. Riverview #300
Anaheim, California 92808 USA
Tel: +1-714-905-5376
www.parsec-corp.com
Contact: Catherine Gutierrez
cgutierrez@parsec-corp.com
Parsec Automation Corp. (Parsec) is the developer of
TrakSYS™, the global leader in real-time operations
& performance management software. TrakSYS™
significantly decreases costs and lead time, to enhance
profitability on the plant floor, fueling Lean, Six Sigma,
TPM and OpEx efforts.
Paul Mueller Company
Table #103
1600 West Phelps Street
Springfield, MO 65802 USA
Tel: +1-417-575-9000
Fax: +1-417-575-9662
www.paulmueller.com/biopharm
Contact: Bill Hons
bhons@paulmueller.com
Paul Mueller Company, centrally located in Springfield,
Missouri, specializes in the design and manufacture of
stainless steel tanks, processing systems and equipment
for the food, dairy, beverage, chemical, biofuels,
pharmaceutical, biotechnology, and pure water industries.
PCI
Table #137
3001 Red Lion Road
Philadelphia, PA 19114 USA
Tel: +1-215-613-3600
Fax: +1-215-613-3601
pciservices.com
Contact: Justin Schroeder
Justin.Schroeder@pciservices.com
PCI supports the global healthcare industry with
development solutions – from Phase I clinical trials
through commercialization and ongoing supply –
that increase speed to market and opportunities
for commercial success. Our clients view us as an
extension of their business and a collaborative partner.
58
ISPE Annual Meeting 2015
PCI Cleanroom
Contracting
Table #77
delivering excellence
11145 Thompson Ave
Lenexa, KS 66219 USA
Tel: +1-800-255-6886
Fax: +1-913-492-8723
pcg.com/cleanrooms
Contact: Sean Marrie
cleanrooms@pcg.com
PCI is the largest cleanroom contractor in the U.S.A.
We provide a tailored, objective, and cost-effective
solution to your exact cleanroom requirements. We are
a $1 billion company with nationwide resources, so we
always deliver for you, no matter how large the project
or aggressive the schedule.
Performance Validation
Table #142
5420 W. Southern Ave
Indianapolis, IN 46241 USA
Tel: +1-317-248-8848
Fax: +1-317-248-0464
www.perfval.com
Contact: Richard Van Doel
rick.vandoel@perfval.com
Performance Validation has been serving the life
science industries since 1988, and is a nationwide
leader in providing validation, commissioning/
verification, temperature mapping, and quality services
for pharmaceutical, biotechnology, and medical device
manufacturers.
Pharmadule Morimatsu
Table #94
33 Bernard Street
Branchburg, NJ 08876 USA
Tel: +1-908-722-6845
Fax: +1-908-722-6845
www.pharmadule.com
Contact: Scott Kaplan
scott.kaplan@pharmadule.com
Complete modular production facilities including
facility design and engineering, process design and
engineering, fabrication, process installation, project
management, commissioning and qualification.
®
PharmaSys, Inc.
Piercan USA, Inc.
Table #92
Table #55
216 Towne Village Drive
Cary, NC 27513 USA
Tel: +1-919-468-2547
Fax: +1-919-468-0147
www.pharma-sys.com
Contact: Mark Davies
PharmaSys, Inc. provides compliance & validation
services to the pharmaceutical, biotech, clinical trial,
medical device and related industries. Visit our website
for information–www.pharma-sys.com.
180 Bosstick Blvd
San Marcos, CA 92069 USA
Tel: +1-760-599-4543
Fax: +1-760-599-0231
www.piercanusa.com
Contact: Taylor Farias
sales@piercanusa.com
PIERCAN provides a global presence, manufacturing
glovebox/isolator gloves in both the United States and
France. Our polymer expertise allows up to offer market
leading gloves for all containment needs.
Pharmatech Associates
Plascore Modular
Cleanroom Systems
Table #105
22320 Foothill Blvd, Suite 330
Hayward, CA 94541 USA
Tel: +1-877-787-0177
Fax: +1-510-732-1992
www.pharmatechassociates.com
Contact: Jerry Beers
jbeers@pharmatechassociates.com
Pharmatech’s services cover four spheres of technical
expertise necessary throughout the complete
product development lifecycle: Product and Process
Development, Compliance, Regulatory, and Validation.
It is this interconnected framework of services which
denotes The Pharmatech EcosystemTM.
PharmEng Technology
Table #96
200-2475 Northwinds Parkway
Alpharetta, GA 30009 USA
Tel: +1-919-474-8309
Fax: +1-416-385-3912
www.pharmeng.com
Contact: Ben Lee
info@pharmeng.com
PharmEng Technology is a fully integrated consulting
firm serving the Biotechnology and Pharmaceutical
industry. We are cGMP compliant leaders in providing
services in C&Q, validation, quality systems, RA, data
integrity, IT, serialization, auditing, process development,
and technology transfer.
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Table #186
615 N. Fairview St.
Zeeland, MI 49464-0170 USA
Tel: +1-616-566-2552
Fax: +1-616-748-2305
www.plascore.com
Contact: Bill Roy
william.roy@plascore.com
Plascore, Inc. is a leading manufacturer of cleanroom
environments specifically designed for the pharmaceutical
industry. Our walls and walkable ceiling systems are
studless and flush in their design. Along with our doors
and windows, the Plascore system provides a complete,
flexible and smooth modular system.
PM Group
Table #64
1740 Technology Drive, Suite 210
San Jose, CA 95110 USA
Tel: +1-408-200-7200
Fax: +1-408-200-7201
www.pmgroup-global.com
Contact: Jeremy Freeman
Jeremy.Freeman@pmgroup-global.com
PM Group is an international, project delivery company
operating across Europe, the USA and Asia. Our 2,100
multi-disciplinary engineering and project management
teams deliver complex capital projects to multinational
clients in the pharmaceuticals; medtech; healthcare and
mission critical sectors.
59
Powerstar
PRI Bio
2650 Lake Shore Drive, Unit 205
Riviera Beach, FL 33404 USA
Tel: +1-561-515-5550
www.powerstar.com
Contact: Intelligent Sustainable Solutions (ISS) LLC
info@powerstar.com
Powerstar voltage optimization systems actively reduce
a considerable percentage of your electrical energy
consumption, cutting CO2 emissions and saving on
electricity costs. Available through ISS, the exclusive
representative for the Powerstar voltage optimization in
the Life Science Industry.
700 Industrial Drive
Dupo, IL 62239 USA
Tel: +1-618-286-5000
Fax: +1-618-286-5009
www.pri-bio.com
Contact: Craig Morley
cmorley@progressive-recovery.com
PRI Bio is the global leader in engineering and
manufacturing Biowaste Effluent Decontamination
Systems. PRI’s systems represent the final boundary
in sterilization treatment of liquid or solid wastes before
discharge to the environment. Since 1983, PRI has
designed and manufactured over 3,100 thermal systems
for industry, government, and research institutions.
Booth #209
PQE
Table #131
605 Main Street
Riverton, NJ 08077 USA
Tel: +39 055 52 75 100
Fax: +39 055 5275142
www.pqe.eu
Contact: Amorosi Francesco
f.amorosi@pqe.eu
PQE is a leading global turnkey solution provider in
the Life Science field specializing in: Data Integrity
Assurance / CSV; Qualification & Engineering; Quality &
Compliance; Regulatory Affairs. We enable companies
to achieve compliance with FDA, EMA and other
international regulatory authorities.
Precis Engineering, Inc.
Table #148
20 South Maple Street
Ambler, PA 19002 USA
Tel: +1-215-540-9800
Fax: +1-215-540-9818
www.precisengineering.com
Contact: Murray A Sterling
msterling@precisengineering.com
Precis Engineering provides strategic MEP/FP solutions
to our client’s complex requirements within the
pharmaceutical and bio-tech industry. Our emphasis
is on critical infrastructure where functionality within
specific parameters isn’t just a guideline – it’s a
requirement.
60
ISPE Annual Meeting 2015
Table #74
ProPharma Group
Table #114
8717 W. 110th St., Suite 300
Overland Park, KS 66210 USA
Tel: +1-888-242-0559
Fax: +1-913-663-2729
www.ProPharmaGroup.com
Contact: Steve Swantek
steve.swantek@propharmagroup.com
ProPharma Group is an industry leader serving the
compliance needs of the pharmaceutical, biotechnology,
and medical device industries. Our comprehensive
compliance services include Compliance, Quality
Assurance, Commissioning and Qualification, Medical
Information, and all validation disciplines.
ProSys Containment &
Sampling Technology
Table #139
3800 Old Mill Rd.
Springfield, OH 45502 USA
Tel: +1-773-663-7650
www.prosys.ie
Contact: Joe Lyons
joe.lyons@prosys.ie
ProSys Containment & Sampling is manufacturer of
custom isolators for high containment requirements.
ProSys has solutions for contained equipment with
integration and automation specifications and delivers
and engineered to order product. ProSys is a leader with
recirculating samplers for API reactors and filter dryers.
PS&S
Table #28
67A Mountain Blvd
Warren, NJ 07059 USA
Tel: +1-732-584-0294
Fax: +1-732-352-6884
www.psands.com/sci-tech
Contact: Luis Silvestre
lsilvestre@psands.com
With ALL the technical disciplines provided in-house,
PS&S continues to be a leading solution provider for
Life Science companies’ facilities, utilities, and capital
project’s needs in the US and globally. PS&S uses a
holistic approach to integrate all projects’ aspects while
minimizing delivery risks.
PTI Inspection Systems
Table #76
Raland Compliance
Partners
Table #160
1387 Fairport Rd, ST 1050
Fairport, NY 14450 USA
Tel: +1-877-972-5263
Fax: +1-866-701-2455
www.raland.com
Contact: Robert Miseyka
info@raland.com
Raland Compliance Partners provides compliance
consultation and guidance for organizations in the
pharmaceutical, biotech and medical device industries.
In all GxP engagements, we strive for immediate
and sustained process improvement, from product
development to patient delivery.
Rescop
145 Main Street
Tuckahoe, NY 10707 USA
Tel: +1-914-337-2005
Fax: +1-914-337-8519
www.ptiusa.com
Contact: Oliver Stauffer
info@ptiusa.com
PTI manufactures non-destructive package quality
inspection and leak testing equipment. Our
technologies provide solutions for CCIT, seal quality
inspection and package integrity/leak detection.
Technologies include vacuum decay (ASTM F2338-09),
airborne ultrasound (ASTM F3004-13) and high voltage
leak detection (HVLD).
Table #169
Puritan Products, Inc.
Sartorius Stedim North
America
Table #135
2290 Avenue A
Bethlehem, PA 18017 USA
Tel: +1-610-866-4225
Fax: +1-610-866-4270
www.puritanproducts.com
Contact: Torey Payne
tpayne@puritanproducts.com
GMP compliant, FDA registered and inspected,
specializing in high purity chemical raw materials.
Product offering includes compendial grade (USP/NF,
EP, JP) acids, bases, salts, and GMP bioreagents. Using
GMP materials, we dilute, dissolute, and blend to make
excipient, process intermediate, and cleaning solutions.
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822 N A1A HWY
Ponte Vedra, FL 32082 USA
Tel: +1-904-473-4932
Fax: +1-904-639-6925
www.rescop.com
Contact: Denis Fischer
d.fischer@rescop.com
Rescop is an innovative provider of quality management
software solutions for the life sciences industry. Its
lifecycle management solution RC-SLM360® enables
regulated manufacturers to streamline and simplify
validation from the conception of a product and during
its commercial manufacturing.
Table #59
5 Orville Drive
Bohemia, NY 11716 USA
Tel: +1-631-254-4249
Fax: +1-631-253-5428
www.sartorius.us
Contact: Carolyn Hartmann
carolyn.hartmann@sartorius-stedim.com
Sartorius Stedim Biotech is a total solution provider for
the biopharmaceutical industry offering re-usable and
Single Use Bioreactors, Microbial Fermenters, Filtration
Devices, Membrane Absorbers, Integrity Testers,
Housings, and comprehensive Single-Use Fluid Handling,
storage and Mixing Technologies, and Cell Culture
61
SKAN US, Inc.
Table #79
7409 ACC Blvd., Suite 200
Raleigh, NC 27617 USA
Tel: +1-919-354-6380
Fax: +1-919-354-6411
www.skan.ch
Contact: Les Edwards
us.sales@us.skan.ch
SKAN is one of the pioneer companies in the field of
cleanroom equipment and isolator design for the global
pharmaceutical industry. Innovative products, customerspecific solutions and an efficient service organisation
have led SKAN to become a global market leader and
important partner for industry and research laboratories.
SNC-Lavalin Project
Services, Inc.
Table #108
436 Creamery Way, Suite 100
Exton, PA 19341 USA
Tel: +1-514-393-8000, ext. 54406
Fax: +1-610-524-2443
www.snclavalin.com
Contact: Richard Fecteau
richard.fecteau@snclavalin.com
SNC-Lavalin provides engineering, procurement,
construction and project management, and
validation/commissioning services dedicated to the
pharmaceutical, biotechnology and life sciences
sectors. We bring innovation and creativity to each
project and clients can be assured of customized,
leading-edge solutions that meet their needs.
SQA Services, Inc.
Table #73
550 Silver Spur Rd.
Rolling Hills, CA 90275 USA
Tel: +1-310-802-4436
Fax: +1-310-544-5541
www.sqaservices.com
Contact: Jason Gutierrez
jasong@sqaservices.com
SQA provides global supplier quality services for
quality-critical industries. With quality, manufacturing,
and regulatory experts located in over 50 countries,
SQA provides a cost-effective, local supplier presence.
62
ISPE Annual Meeting 2015
STERIS Life Sciences
Table #124
5960 Heisley Road
Mentor, OH 44060 USA
Tel: +1-215-794-4542
www.sterislifesciences.com
Contact: David Knauer
David_Knauer@steris.com
For over 100 years STERIS Corporation has been
known as a global leader, trusted partner and solutions
provider in the field of sterilization and contamination
control. From Formulated Chemistries, to Capital
Equipment to Parts and Services, STERIS Life
Sciences is Science and Solutions for Life. www.
sterislifesciences.com
STILMAS USA, LLC
Table #87
1361 Lincoln Ave # 7
Holbrook, NY 11741 USA
Tel: +39 349 5935927
Fax: +39 02950806626
www.stilmas.com
Contact: Cristian Bavuso
cristianbavuso@stilmas.com
Stilmas, a company with more than a century of history,
is specialized in design and manufacturing of high
technology plants for the production of clean utilities
(water and steam) for the pharmaceutical industry in
compliance with standards required by international
regulatory bodies.
Stonhard
Table #104
1000 E. Park Ave.
Maple Shade, NJ 08052 USA
Tel: +1-800-257-7953
Fax: +1-856-321-7525
www.stonhard.com
Contact: Tom Burns
info@stonhard.com
Stonhard is the world’s leading manufacturer and
installer of superior flooring and wall coating solutions
for the Life Sciences industry. We welcome you to
stop by the exhibit to learn more about the Stonhard
Difference.
Suvoda
Thermo Fisher Scientific
6 Tower Bridge 181 Washington St., Suite 200
Conshohocken, PA 19428 USA
Tel: +1-610-572-2920
Fax: +1-610-572-2920
www.suvoda.com
Contact: Anthony Encarnacao
anthony@suvoda.com
The team that brought you the first fully web-integrated
interactive response technology and the industry’s
shortest timelines now brings you Suvoda IRT: a
reimagined randomization and trial supply management
system.
5791 Van Allen Way
Carlsbad, CA 92008 USA
Tel: +1-800-955-6288
www.thermofisher.com/bioproduction
Contact: Carsten Lau
infobpd@thermofisher.com
To learn more visit us at www.thermofisher.com/sut
Table #56
We believe rapid deployment, system flexibility, and
advanced reporting are just starting points.
Swisslog
Table #90
161 Enterprise Dr.
Newport News, VA 23603-1369 USA
Tel: +1-757-820-3616
Fax: +1-757-820-3616
www.swisslog.com/en/WDS/NA-North-America-WDS
Contact: Bill Leber
bill.leber@swisslog.com
Swisslog designs, develops and delivers best-in-class
automation solutions for forward-thinking hospitals,
warehouses and distribution centers. We offer integrated
systems and services from a single source – from
consulting to design, implementation and lifetime
customer service.
Texas A&M University
Table #156
100 Discovery Dr.
College Station, TX 77843-4482 USA
Tel: +1-979-458-8506
Fax: +1-979-847-5857
nctm.tamu.edu
Contact: National Center for Therapeutics Manufacturing
programs@nctmmail.tamu.edu
The National Center for Therapeutics Manufacturing
(NCTM) located at Texas A&M University in College
Station, Texas, is an interdisciplinary education
institution that provides multi-generational technical
training and professional development programs for the
biopharmaceutical and vaccine manufacturing industries.
CONNECT SHARE FOLLOW #ISPEAM15
Table #57
Tote Systems
Table #122
8821 Forum way, Suite 113
Fort Worth, TX 76140 USA
Tel: +1-817-447-9110
Fax: +1-817-447-7801
www.totesystems.com
Contact: Chris Ducic
cducic@totesystems.com
Since the first Tote in 1946, we have followed our
corporate goal to be the industry leader and to focus
on affordable, robust on time solutions to meet the
demanding industry needs of today. We are proud of our
commitment, professionalism and the rewards gained
through the many years working with our loyal client base.
TSI Inc.
Table #132
500 Cardigan Road
Shoreview, MN 55126 USA
Tel: +1-800-874-2811
Fax: +1-651-490-3824
www.tsi.com
Contact: Rich Remiarz
Rich.Remiarz@tsi.com
“TSI’s monitoring solutions include the BioTrak® RealTime Viable Particle Counter and AeroTrak™ Handheld,
Portable and Remote Particle Counters, as well as
Facility Monitoring Systems.”
63
TSS - Temperature Sensitive
Solutions
Table #128
Mallslingan 20a
Täby, Stockholm, 18766 Sweden
Tel: +46(0)86300606
Fax: +46(0)8 6300654
www.tss.se
Contact: Sanna Persson
sanna.persson@tss.se
TSS’ cloud temperature monitoring system, CCIS,
is developed in close collaboration with leading
pharmaceutical companies. CCIS is a lean and integrated
solution that provides flexibility, simplicity, reliability, and
above all, full visibility, throughout the whole organization.
10-D Gill Street
Woburn, MA 01801 USA
Tel: +1-888-824-7252
Fax: +1-781-933-8029
www.vaisala.com
Contact: Kevin Belisle
instruments@vaisala.com
Vaisala provides high-performance monitoring,
measurement and validation systems for regulated
and GxP environments. With fail-safe monitoring and
alarming of humidity, temperature, CO2, differential
pressure and more, Vaisala provides the most reliable
solutions and support worldwide.
Tunnell Consulting
ValGenesis, Inc
900 East Eighth Avenue, Suite 106
King of Prussia, PA 19406 USA
Tel: +1-610-337-0820
Fax: +1-610-337-1884
www.tunnellconsulting.com
Contact: Maryann Wilhelm, Director of Marketing
wilhelm@tunnellconsulting.com
Tunnell Consulting: Founded in 1962 and with a sole
focus in the Life Sciences, our capabilities include:
Cost Reduction, Operational Excellence, Business
Transformation, Process Improvement, Process
Understanding, Technology Transfer, Continued Process
Verification, Quality and Regulatory Compliance.
42840 Christy St., Suite 102
Fremont, CA 94538-3154 USA
Tel: +1-510-445-0505
Fax: +1-510-991-9901
www.valgenesis.com
Contact: Siva Samy
samy@valgenesis.com
ValGenesis - Validation Lifecycle Management software
solution manages the end to end validation Lifecycle
process for any GxP system or process. ValGenesis is
the trusted solution by global Life science companies.
Table #182
Table #37
UFP Technologies
Booth #205
172 East Main Street
Georgetown, MA 01833 USA
Tel: +1-978-352-2200
Fax: +1-978-352-7169
www.ufpt.com
Contact: Tuna Sava
tsava@ufpt.com
UFP Technologies is a producer of innovative, customengineered solutions for the biopharmaceutical industry.
Our solutions range from shipping/storage systems
for bulk pharmaceuticals, advanced insulation for
cleanroom environments, and high purity foam caps
used to block and protect sanitary ends.
64
Vaisala, Inc.
ISPE Annual Meeting 2015
Table #113
Validation Technologies
Incorporated
Table #144
10815 Rancho Bernardo Road, Suite 102
San Diego, CA 92127 USA
Tel: +1-800-930-9222
www.validation.org
Contact: Robert Cote’
robert.cote@validation.org
Validation Technologies, Inc. (VTI) is an ISO 9001:2000
Certified Company with the experience, expertise, and
commitment to provide the superior service required to
meet all of your validation and compliance needs. We
offer a full spectrum of services, including computer
validation, cleaning validation, process validation.
Veeva
VNE Corporation
4637 Chabot Drive
Pleasanton, CA 94588 USA
Tel: +1-925-452-6500
Fax: +1-925-452-6504
www.veeva.com
Contact: Sangita Patel
sangita.patel@veeva.com
Veeva Systems Inc. is a leader in cloud-based software
for the global life sciences industry. Committed to
innovation, product excellence, and customer success,
Veeva has more than 275 customers, ranging from the
world’s largest pharmaceutical companies to emerging
biotechs.
PO Box 1698
Janesville, WI 53547 USA
Tel: +1-608-756-4930
Fax: +1-608-756-3643
www.vnestainless.com
Contact: Pete Dunbar
pdunbar@vnecorp.com
VNE Corporation, is a member of the NEUMO
Ehrenberg Group Companies. VNE supplies the ASME
BPE certified MaxPure® hygienic fittings for the global
biopharmaceutical industry and other high purity
applications. VNE maintains one of the largest BPE
fittings inventory in the USA for domestic and worldwide
distribution.
Booth #221
Veltek Associates, Inc.
Table #162
Table #91
Walker Barrier Systems
15 Lee Blvd
Malvern, PA 19355-1235 USA
Tel: +1-610-644-8335
Fax: +1-610-644-8336
www.sterile.com
vai@sterile.com
VAI, an EPA/FDA registered manufacturing facility,
specializes in the control of contamination in classified
areas. VAI produces sterile pharmaceutical grade
disinfectants, sanitizers, sporicides, cleaners, lubricants
and detergents. Additionally we offer, viable monitoring
equipment, cleaning equipment, and cleanroom paper
and supplies.
Table #120
Villanova University
Graduate Engineering
Studies
Watson-Marlow Fluid
Technology Group
Table #F1
800 E. Lancaster Ave | CEER
Villanova, PA 19085 USA
Tel: +1-610-519-6723
www.gradengineering.villanova.edu
Contact: Meg Amis
megan.amis@villanova.edu
Earn an MS in Biochemical Engineering in as little as
two years. Full-time, part-time, on campus or online
– Villanova University’s graduate programs offers
flexible options for working professionals. Students can
custom-tailor course selections to align with career
goals while balancing work and family life.
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618 State Street
New Lisbon, WI 53950 USA
Tel: +1-608-562-7761
Fax: +1-698-562-7762
www.walkerbarrier.com
Contact: Gary Partington
gpartington@walkerbarrier.com
Walker Barrier Systems designs and builds isolators for
aseptic product testing, processing and filling, as well as
containment isolators and downflow booths for operator
protection. We also design and build RABs and Mobile
Clean Rooms.
Booth #204
37 Upton Technology Park
Wilmington, MA 01887 USA
Tel: +1-800-282-8823
Fax: +1-978-658-0041
www.wmftg.com
Contact: Peter Lambert
support@wmpg.us
Watson-Marlow is the leading manufacturer of peristaltic
pumps, high-purity tubing, BioPure single-use bio
processing components, Flexicon aseptic filling solutions
and Asepco high purity valves and magnetic mixers.
65
Weiss Envirotronics
World Courier, Inc.
Table #116
Table #167
7424 ACC Blvd, Suite 102 Pharma Business Unit
Raleigh, NC 27613 USA
Tel: +1-919-616-2694
Fax: +1-616-554-5021
www.envirotronics.com
Contact: Mark Holland
mholland@envirotronics.com
Weiss Envirotronics offers reliable solutions for the
pharmaceutical industry. Our complete line of products
offer FDA and GMP compliant chambers for stability
testing, barrier systems, sterilization and drying and
clean rooms. We offer bench top, reach in and walk in
options. We also offer custom solutions.
1313 4th Avenue
New Hyde Park, NY 11040 USA
Tel: +1-800-221-6600
Fax: +1-516-354-7227
www.worldcourier.com
Contact: Michael Gordon
sales@worldcourier.com
World Courier is a global specialty logistics company
who designs world-class logistics & supply chain
programs. Pharmaceutical companies depend on
our unsurpassed knowledge, global reach & flawless
supply chain execution. More than 140 offices across
the globe, we offer on-time, on-temperature delivery of
critical products.
WGS Equipment &
Controls Inc
Zenith Technologies
3060 Plaza Drive, Suite 110
Garnet Valley, PA 19060 USA
Tel: +1-610-459-8800
Fax: +1-610-459-8848
www.wgsequipment.com
Contact: Jack Fetrow
jack@wgsequipment.com
WGS Equipment & Controls is a manufacturer
representative of process control and analytical
instrumentation used extensively within the biotech and
pharmaceutical industry. We offer start-up, calibration
services along with contractual services contracts.
751 Arbor Way (Suite 115)
Blue Bell, PA 19422 USA
Tel: +1-610-234-3173
Fax: +1-610-825-4310
www.zenithtechnologies.com
Contact: Michael Smith
mike.smith@zenithtechnologies.com
Zenith Technologies operate 100% in Life Sciences,
we are world leaders in delivering manufacturing
software systems that make businesses compliant and
competitive. We specialize in automation and workflow
solutions that manage and control manufacturing plants
to improve operational effectiveness.
Table #145
Wilco
Table #127
21 Commerce Dr.
North Branford, CT 06471 USA
Tel: +1-203-484-9100
Fax: +41.56.618.4344
www.wilco.com
Contact: Paul Bilotti
paul.bilotti@wilco.com
WILCO’s core business includes non-destructive CCIT
Technologies, like Mass spectrometry, Headspace
Analysis, Pressure/Vacuum decay and Force Sensor, as
well as Visual Inspection Technologies, like X-Ray and
the newly launched High Speed Camera based Visual
Inspection System.
66
ISPE Annual Meeting 2015
Table #138
Hotel Map
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MTG
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RM 412
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RM 410
FRANKLIN HALL
EXHIBITOR
STORAGE
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Student Posters
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TRAINING COURSES
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Level 5
SALON A
SALON L
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KEYNOTE
EDUCATION
SESSIONS
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SALON C
SALON D
SALON K
GRAND
BALLROOM
SALON J
MEMBERSHIP
BREAKFAST
AND AWARDS
EDUCATION
SESSIONS
SALON E
SALON H
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INDEPENDENCE BALLROOM
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ISPE Annual Meeting 2015
MAKING THE COMPLEX
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Event Schedule
SATURDAY, 7 NOVEMBER
15.00 – 17.00
Opening Keynote
Grand A-F (Level 5)
08.30 – 11.30
Executive Committee
413 (Level 4)
17.00 – 19.00
Exhibit Hall Open
Franklin Hall (Level 4)
11.00 – 17.00
Speaker/Volunteer Lounge
309-310 (Level 3)
17.00 – 19.00
Welcome Reception in the Exhibit Hall
Franklin Hall (Level 4)
11.00 – 18.00
Registration Open
Levels 4 and 5
MONDAY, 9 NOVEMBER
13.00 – 16.00
Board of Directors
414-415 (Level 4)
06.30 – 08.00
Charity 5K Run/Walk
buses depart: 12th Street Entrance (Lobby level)
16.30 – 17.15
2015 Annual Meeting Strategy & Program Committee
402-403 (Level 4)
07.00 – 08.30
Grab-and-Go Coffee Plus Food for Purchase
Level 5
SUNDAY, 8 NOVEMBER
07.00 – 17.30
Registration Open
Levels 4 and 5
07.00 – 19.00
Registration Open
Levels 4 and 5
07.00 – 17.00
Press Room
308 (Level 3)
08.00 – 12.30
Knowledge Network Council
408-409 (Level 4)
07.00 – 17.30
Speaker/Volunteer Lounge
309-310 (Level 3)
08.00 – 15.00
Speaker/Volunteer Lounge
309-310 (Level 3)
07.15 – 08.15
08.00 – 16.00
Exhibitor Set Up
Franklin Hall (Level 4)
New Member and First-Time Attendee Orientation
& Networking Breakfast
Independence I-III (Level 3 across bridge to
convention center)
08.30 – 09.30
Student Poster Set Up
4th floor foyer
08.00 – 08.15
Young Professionals Meet and Greet
307 (Level 3)
08.30 – 11.45
Young Professionals Steering Committee
414-415 (Level 4)
08.30 – 17.00
Training Course: T19 Practical Application of
Technology Transfer
414-415 (Level 4)
08.30 – 14.30
Joint Affiliate Council
Grand H (Level 5)
08.30 – 17.00
10.00 – 12.30
GAMP ER/ES GPG Team
307 (Level 3)
Training Course: T43 Turning QbD into a Practical
Reality
408-409 (Level 4)
08.30 – 17.00
10.00 – 15.00
Quality Metrics Core Team Meeting
402-403 (Level 4)
Training Course: T50 GAMP: Data Integrity
411-412 (Level 4)
08.30 – 10.00
Education Session 1-101: Managing Abstract
Elements Beyond Facilities
Grand G (Level 5)
08.30 – 10.00
Education Session 1-109: 2015 Facility of the Year
Category Winners
Grand L (Level 5)
08.30 – 10.00
Education Session 2-201: Combination Products
Liberty C (Level 3 across bridge to convention
center)
08.30 – 10.00
Education Session 2-217: FDA: Trends in
Compliance, Enforcement, cGMPs and Quality
Grand H (Level 5)
12.00 – 15.00
Investigational Products NA CoP Steering Committee
408-409 (Level 4)
12.30 – 13.30
Young Professionals/Students Luncheon and
Orientation
Grand G (Level 5)
12.30 – 15.00
Biotech CoP Steering Committee
303 (Level 3)
13.00 – 15.00
Pharmaceutical Engineering Committee
304 (Level 3)
13.00 – 15.00
Guidance Documents Committee Part 1
Room
08.30 – 10.00
13.00 – 15.00
Active Pharmaceutical Ingredients CoP Steering
Committee
307 (Level 3)
Education Session 3-301: Implementing
Single-Use Technology in Scale-up
Grand K (Level 5)
08.30 – 10.00
13.00 – 15.00
Facilities and Equipment Network CoP Steering
Committee
302 (Level 3)
Education Session 4-401: Pragmatic Approaches
to Data Integrity – Part 1
Grand J (Level 5)
08.30 – 10.00
13.00 – 17.00
Press Room
308 (Level 3)
Education Session 5-501: Patient Initiative: Survey
Results and Real World Applications
Liberty A-B (Level 3 across bridge to
convention center)
Networking, Lunch, Tours & Meetings
70
ISPE Annual Meeting 2015
Facilities and Equipment
Regulatory Compliance & Quality Systems
Information Systems
08.30 – 10.00
Education Session 6-601: The Future of Pharma
Manufacturing – The Next 100 Years
Grand I (Level 5)
13.30 – 15.00
Education Session 1-114: Baxter Integrated
Plasma Protein Manufacturing Facility
Grand G (Level 5)
09.00 – 11.00
Affiliate/Chapter Managers Meeting
302 (Level 3)
13.30 – 15.00
09.30 – 18.30
Exhibit Hall Open
Franklin Hall (Level 4)
Education Session 2-216: Hot Topics in Validation,
Part 2
Liberty C (Level 3 across bridge to convention
center)
10.00 – 12.00
Headshot Portraits
Exhibit Hall Lobby
13.30 – 15.00
Education Session 2-213: Data Integrity Trends:
Regulatory and Compliance Perspective
Grand H (Level 5)
10.00 – 10.45
Networking Break in the Exhibit Hall
Franklin Hall (Level 4)
13.30 – 15.00
10.45 – 12.15
Education Session 1-102: 12 Flexible Facility
Biopharm Projects
Grand G (Level 5)
Education Session 3-303: Single-Use
Standardization Update
Grand K (Level 5)
13.30 – 15.00
Education Session 5-503: Clinical Supplies and
the Investigator Site
Liberty A-B (Level 3 across bridge to
convention center)
13.30 – 15.00
Education Session 6-604: Rapid Deployment
Modular Operations and Hybrid Facilities
Grand I (Level 5)
13.30 – 15.30
North America/South America Affiliates Council
Independence I-III (Level 3 across bridge to
convention center)
13.30 – 17.00
International Student Poster Competition
401-403 (Level 4)
15.00 – 16.00
Disposables CoP Steering Committee
307 (Level 3)
15.00 – 16.00
Oral Solid Dosage CoP Steering Committee
303 (Level 3)
15.00 – 16.00
Operations Management CoP Steering Committee
302 (Level 3)
15.00 – 16.00
HVAC/Sustainable CoP Steering Committee
304 (Level 3)
15.00 – 16.00
Networking Break in the Exhibit Hall
Franklin Hall (Level 4)
16.00 – 17.30
Global Regulatory Town Hall
Grand A-F (Level 5)
17.30 – 18.30
Mix and Mingle Reception in the Exhibit Hall
Franklin Hall (Level 4)
Young Professionals Event
Lucky Strike - off property
10.45 – 12.15
Education Session 1-110: A Decade of Data:
Facility of the Year Aggregate Metrics
Grand L (Level 5)
10.45 – 12.15
Education Session 2-202: Hot Topics in Validation,
Part 1
Liberty C (Level 3 across bridge to convention
center)
10.45 – 12.15
Education Session 2-212: Business Continuity
Planning for Prevention of Drug Shortages:
Introducing the ISPE Drug Shortages Assessment
and Prevention Tool
Grand H (Level 5)
10.45 – 12.15
Education Session 3-302: Impact of Single-Use
Manufacturing on Process Development
Grand K (Level 5)
10.45 – 12.15
Education Session 3-314: Current Trends in Barrier
and Aseptic Technologies Independence I-III
(Level 3 across bridge to convention center)
10.45 – 12.15
Education Session 4-402: Pragmatic Approaches
to Data Integrity – Part 2
Grand J (Level 5)
10.45 – 12.15
Education Session 5-502: Patient Unfriendly to
Patient-friendly and Compliance in CT
Liberty A-B (Level 3 across bridge to
convention center)
10.45 – 12.15
Education Session 6-602: Gaining Control of the
Quality Culture and Workforce Behavior
Grand I (Level 5)
19.30 – 22.00
11.00 – 12.00
Brazil Affiliate Meeting
307 (Level 3)
TUESDAY, 10 NOVEMBER
11.30 – 13.00
GAMP MES SIG
406 (Level 4)
12.15 – 13.30
Lunch and Networking in the Exhibit Hall
Franklin Hall (Level 4)
13.30 – 15.00
Education Session 1-103: GMP in Aging Facilities
and Upgrade of Existing Facilities
Grand L (Level 5)
13.30 – 15.00
Education Session 1-111: The Latest OSD
Regulation Requirements and Technologies
Grand J (Level 5)
Training
End-to-End Supply Chain Management
07.00 – 17.00
Registration Open
Levels 4 and 5
07.00 – 17.00
Press Room
308 (Level 3)
07.00 – 17.00
Speaker/Volunteer Lounge
309-310 (Level 3)
07.30 – 07.45
Young Professionals Meet and Greet
307 (Level 3)
08.00 – 10.00
Membership Breakfast and Awards Ceremony
Grand A-F (Level 5)
Innovation Forum
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Product Development and Production Systems
71
Event Schedule
08.30 – 17.00
Training Course: T19 Practical Application of
Technology Transfer
414-415 (Level 4)
13.30 – 15.00
Training Course: T43 Turning QbD into a Practical
Reality
408-409 (Level 4)
Education Session 1-113: Integration of
Environmental Health and Safety Requirements
Independence I-III (Level 3 across bridge to
convention center)
08.30 – 17.00
13.30 – 15.00
08.30 – 17.00
Training Course: T50 GAMP®: Data Integrity
411-412 (Level 4)
Education Session 2-205: FDA Update from the
Office of Pharmaceutical Quality
Grand H (Level 5)
13.30 – 15.00
09.30 – 16.00
Exhibit Hall Open
Franklin Hall (Level 4)
Education Session 2-206: Process Capability for
Continuous Improvement, Part 2
Liberty C (Level 3 across bridge to convention
center)
10.00 – 10.45
Networking Break in the Exhibit Hall
Franklin Hall (Level 4)
13.30 – 15.00
Education Session 3-305: New Directions in
Continuous Process for mAb Manufacturing
Grand L (Level 5)
10.00 – 12.00
Guidance Documents Committee Part 2
304 (Level 3)
13.30 – 15.00
10.30 – 13.00
Asia-Pacific Affiliates Council
307 (Level 3)
Education Session 3-309: Biomanufacturing
Capacity Improvement – Process Modeling
Grand G (Level 5)
13.30 – 15.00
10.45 – 12.15
Education Session 1-104: Implementing
Single-Use Technology for Biomanufacturing
Grand G (Level 5)
Education Session 4-405: Clinical Data Archiving
and eTMF Migration Case Study
Grand J (Level 5)
13.30 – 15.00
10.45 – 12.15
Education Session 1-112: Critical Utilities
Maintenance and Operational Optimization
Independence I-III (Level 3 across bridge to
convention center)
Education Session 5-505: Counterfeit Medicines
and Serialization/Track and Trace
Liberty A-B (Level 3 across bridge to
convention center)
13.30 – 15.00
Education Session 1-116: Cross Contamination:
Dedication, Segregation or Other?
Grand K (Level 5)
Education Session 6-607: Asia-Pacific GMP
Update; Innovative Technologies in China
Grand I (Level 5)
13.30 – 15.30
Pharmaceutical Critical Utilities Users Group
406 (Level 4)
13.30 – 17.30
Quality Metrics Core Team Meeting
305-306 (Level 3)
14.00 – 15.30
Facility of the Year Awards Committee
307 (Level 3)
14.00 – 17.30
2015/2016 Board of Directors
401-402 (Level 4)
15.00 – 16.00
Sterile Products Processing CoP Steering Committee
304 (Level 3)
15.00 – 16.00
Networking Break in the Exhibit Hall
Franklin Hall (Level 4)
15.30 – 17.00
Membership Development Committee
403 (Level 4)
16.00 – 17.00
PQLI Meeting
404 (Level 4)
16.00 – 17.30
Education Session 1-106: Decommissioning
Pharmaceutical Equipment and Facilities
Grand J (Level 5)
16.00 – 17.30
Education Session 1-115: HVAC Sustainability
Independence I-III (Level 3 across bridge to
convention center)
16.00 – 17.30
Education Session 2-214: International Regulatory
Updates
Grand H (Level 5)
10.45 – 12.15
72
10.45 – 12.15
Education Session 2-204: Process Capability for
Continuous Improvement, Part 1
Liberty C (Level 3 across bridge to
convention center)
10.45 – 12.15
Education Session 2-207: Quality Risk
Management Principles in Breakthrough Therapy
Grand L (Level 5)
10.45 – 12.15
Education Session 3-304: Successful Product
Launches
Grand H (Level 5)
10.45 – 12.15
Education Session 4-404: Specialized eClinical
Solutions for Clinical Trial Processes
Grand J (Level 5)
10.45 – 12.15
Education Session 5-504: Customs and Border
Protection (CBP) and Roundtable
Liberty A-B (Level 3 across bridge to
convention center)
10.45 – 12.15
Education Session 6-603: 21st Century Roadmap;
Critical Data Integrity Success Factors
Grand I (Level 5)
10.45 – 12.15
Drug Shortages Task Team
305-306 (Level 3)
11.00 – 12.00
2016 Annual Meeting Strategy Team
406 (Level 4)
12.15 – 13.30
Lunch and Networking in the Exhibit Hall
Franklin Hall (Level 4)
16.00 – 17.30
Education Session 2-211: Case Studies in
Suspect Product Notification Reporting
Grand Salon C-D (Level 5)
13.30 – 15.00
Education Session 1-105: Convergence of
Continuous Processing and Single-Use Technology
Grand K (Level 5)
16.00 – 17.30
Education Session 3-306: Workflows and New
Technologies in Continuous Processing
Grand L (Level 5)
ISPE Annual Meeting 2015
16.00 – 17.30
Education Session 3-310: C&Q Project
Management – the Ultimate Challenge!
Liberty C (Level 3 across bridge to convention
center)
16.00 – 17.30
Education Session 4-406: The Challenge of IT
Infrastructure
Grand K (Level 5)
16.00 – 17.30
Education Session 4-403: Compliant Regulated
Mobile Applications
Grand G (Level 5)
08.30 – 10.00
Education Session 5-507: English-only Labels;
Use of Pictograms as Universal Language
Grand F (Level 5)
08.30 – 10.00
Education Session 6-605: Achieving Innovation in
Science Facilities Design
Grand I (Level 5)
09.00 – 10.30
Packaging CoP Steering Committee
304 (Level 3)
09.00 – 12.00
GAMP Global
307 (Level 3)
09.00 – 16.00
Facility Tour #1 – Merck’s Gardasil Vaccine
Production Facility
buses depart: 12th Street Entrance (Lobby Level)
16.00 – 17.30
Education Session 5-506: Metrics for Material
Supply Chain: EU Regulatory Challenges
Liberty A-B (Level 3 across bridge to
convention center)
16.00 – 17.30
Education Session 6-606: BioPharm Appropriation
Packages; Project Capital Efficiency
Grand I (Level 5)
09.40 – 20.00
Facility Tour #2 – Morphotek’s Sustainable Facility
of the Year
buses depart: 12th Street Entrance (Lobby Level)
16.15 – 18.00
Exhibitor Move Out
Franklin Hall (Level 4)
09.40 – 20.00
Facility Tour #3 – AstraZeneca’s New Formulation Suite
buses depart: 12th Street Entrance (Lobby Level)
18.45 – 22.00
Tuesday Night Party
Reading Terminal Market (off-property – meet
in the lobby)
10.00 – 10.30
Networking Break
Level 5 foyer
10.30 – 12.00
Education Session 1-108: The China Challenge –
Construction Projects in China
Grand E (Level 5)
10.30 – 12.00
Education Session 2-210: Quality Metrics, Part 2
Grand H (Level 5)
10.30 – 12.00
Education Session 2-208: End-to-End Product
Risk Management
Grand C (Level 5)
10.30 – 12.00
Education Session 3-308: Advances of Single-Use
Tech in a Structured Environment
Grand L (Level 5)
10.30 – 12.00
Education Session 3-312: Antibody Drug
Conjugates – An Opportunity and a Challenge
Grand K (Level 5)
10.30 – 12.00
Education Session 3-313: Best Practices for
Developing 3rd Party API Supplier Partners
Grand J (Level 5)
WEDNESDAY, 11 NOVEMBER
(Veteran’s Day)
07.00 – 08.30
Critical Utilities CoP Steering Committee
303 (Level 3)
07.00 – 08.30
Containment CoP Steering Committee
302 (Level 3)
07.00 – 08.30
Grab-and-Go Coffee Plus Food for Purchase
Level 5
07.00 – 12.00
Registration Open
Level 5
07.00 – 13.00
Press Room
308 (Level 3)
07.30 – 08.30
2015/16 Executive Committee
306 (Level 3)
08.00 – 08.15
Young Professionals Meet and Greet
307 (Level 3)
10.30 – 12.00
08.30 – 10.00
Education Session 1-107: Risk-Based Qualification
– 10 Years Later
Grand J (Level 5)
Education Session 4-408: Serialization and Track
and Trace – Part 2
Grand D (Level 5)
10.30 – 12.00
Education Session 5-508: Early Access to
Investigational Medicines
Grand F (Level 5)
10.30 – 12.00
Education Session 6-608: New Pharmaceutical
Systems; Legacy Product Quality Issues
Grand I (Level 5)
12.30 – 14.00
C&Q CoP Steering Committee
304 (Level 3)
12.30 – 16.00
GAMP Americas CoP Steering Committee
307 (Level 3)
08.30 – 10.00
Education Session 2-209: Quality Metrics, Part 1
Grand H (Level 5)
08.30 – 10.00
Education Session 2-203: Applying Risk-Based
Validation to Move to an ASTM E2500
Grand E (Level 5)
08.30 – 10.00
Education Session 3-307: Advances in Next
Generation Manufacturing
Grand A (Level 5)
08.30 – 10.00
Education Session 3-311: PAT in Raw Materials
Grand B (Level 5)
12.30 – 16.00
08.30 – 10.00
Education Session 4-407: Serialization and Track
and Trace – Part 1
Grand D (Level 5)
Process Analytical Technology CoP Steering
Committee
302 (Level 3)
12.30 – 16.00
C&Q Document Drafting Team
303 (Level 3)
08.30 – 10.00
Education Session 4-409: Improving Your
Interactions with Cloud Providers
Grand C (Level 5)
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73
General Information
and On-Site Services
Wireless Access:
SSID: ISPEWiFibyCAI
Password: cai@224
Sponsored by:
Attire:
ISPE Booth: Level 5 Foyer
Attire for all ISPE Annual Meeting delegate functions
is business casual. The evening functions are casual.
Temperatures in meeting rooms tend to be cool so
bring a light jacket or sweater.
Visit the ISPE Booth and find out the benefits of being a
Member. Already a Member? Discover benefit opportunities
and discounts available to you. Don’t forget to pick up your
Affiliate or Chapter’s ribbon. A guaranteed conversationstarter — wear it with pride!
Registration:
Level 4 – Exhibitor Registration
Level 5 – Attendee Registration
Saturday, 7 November...........11.00 – 18.00
Sunday, 8 November..............07.00 – 19.00
Monday, 9 November.............07.00 – 17.30
Tuesday, 10 November...........07.00 – 17.00
Wednesday, 11 November.....07.00 – 12.00
Info Desk: Level 5
Press Room: 308 (Level 3)
Special Membership Offer: Join before the end of the Annual
Meeting and SAVE $75 on a new ISPE membership! (Offer
applies to new memberships only and may not be used for
renewals.)
Help a Student – Be a Mentor:
Industry professionals volunteer to serve as Mentors and are
wearing a pale green ribbon. If you would like to serve as a
Mentor, stop by ISPE Registration to pick up your ribbon.
Speaker/Volunteer Lounge: 309-310 (Level 3)
Stop by the Registration Desk or the ISPE Booth
if you have any questions about Annual Meeting
events, room locations, etc. Our staff will be wearing
white ISPE staff badges.
The Speaker/Volunteer Lounge is one of the ways ISPE
recognizes the hard work of the volunteers who dedicate
their time to work on Society initiatives. Enjoy complimentary
wireless internet access, desktop computer and access to
a printer in your temporary onsite office. All Speakers must
check-in with a member of the education staff to receive their
speaker packet.
Committee Meetings:
Career Solutions:
A complete list of Committee Meetings can be found
in the Annual Meeting Schedule on page 68. Please
remember that these meetings are for appointed
Members of the Committees only.
Find a Job … or a New Employee
Need Help:
Special Requirements:
If you require special accommodations to participate
in any of our events, please visit us at the ISPE
Registration Desk.
Messages:
We will not be able to make announcements in the
meeting rooms or the Exhibit Hall.
Please be courteous and turn cell phones to silent
mode during all events.
Find your next exciting job opportunity or your next great
employee using ISPE Career Solutions. Pick up copies of
current Hot Jobs by visiting Career Solutions near ISPE’s
Membership booth. Also learn about the benefits of posting
your open positions on ISPE’s online job board.
Mobile Charging Station Info:
Recharge on Level 5 in the ISPE Booth area.
Sponsored by:
General Notice:
Bring your business card to events for networking
with other delegates. Your name and address may
be given to other organizations. Please notify ISPE
Headquarters in writing if you do not wish to share
your information.
Free Headshot Portraits: Level 4 Lobby
Monday 10.00 – 12.00
OFF GUIDANCE
DOCUMENTS
74
ISPE Annual Meeting 2015
ISPE Members receive 20% off all Guidance Documents
purchased on site. Stock up and take advantage of the
savings! Visit the Bookstore to purchase.
www.cockram.com
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75
Young Professionals and Students
Schedule and Events
International Student Poster Competition
Sunday, 8 November
Student Poster Competition Set-Up
08.30 – 09.30
Young Professionals and Students Luncheon and
Orientation
12.30 – 13.30
Monday, 9 November
New Member/First-Time Attendee Orientation
07.15 – 08.15
MONDAY, 9 NOVEMBER
13.30 – 17.00
Room: 401-403 (Level 4)
Student poster finalists from around the world showcase
visual displays of their research or program highlights.
A panel of distinguished industry judges will select the
international graduate and undergraduate winners on
Monday, 9 November. They will be recognized at the
Annual Meeting Membership Breakfast and Awards
Ceremony on Tuesday, 10 November and in ISPE
publications.
Sponsored by:
Young Professionals Meet and Greet
08.00 – 08.15
LIFE SCIENCES TECHNOLOGY SPECIALISTS
International Student Poster Competition
13.30 – 17.00
Young Professionals Networking Event at Lucky Strike
19.30 – 22.00
Tuesday, 10 November
Young Professionals Meet and Greet
07.30 – 07.45
New Member/First-Time
Attendee Orientation
MONDAY, 9 NOVEMBER
07.15 – 08.15
Independence (Level 3 across bridge to
Convention Center)
For new ISPE Members and First-Time Annual Meeting
attendees only (Included in Full and Monday‑Only
Registrations)
New to ISPE? Is this your first ISPE Annual Meeting?
Find out how to make the most of your Annual Meeting
experience and ISPE membership while you enjoy a
continental breakfast. Bring your business cards. You’ll
quickly build your lifelong professional network with one
of our most popular events: Speed Networking.
Young Professionals Networking Event
MONDAY, 9 NOVEMBER 2015
19.30 – 22.00
Lucky Strike
$58
Get ready for a fun networking event that can bring
out your competitive spirit. Bowling, shoes, food and
soft drinks are included. Hosted by ISPE’s Young
Professionals. (Cash bar)
76
ISPE Annual Meeting 2015
Networking Events
Sunday Reception in the Exhibit Hall
Mix and Mingle Reception in Exhibit Hall
17.00 – 19.00
17.30 – 18.30
Sunday, 8 November
Monday, 9 November
$50
$35
Don’t miss the first networking opportunity of the meeting,
the Welcome Reception in the Exhibit Hall. Discuss and
share ideas about industry innovation and new technologies
with your colleagues and more than 200 solution providers.
Gain inspiration from the 2015 Facility of the Year Award
Winners at their dedicated display. Light food will be
provided, as well as two drink tickets.
Membership Breakfast and Awards Ceremony
Sponsored by:
delivering excellence
7th Annual 5K Charity Run/Walk
Monday, 9 November
06.30 – 08.00
Buses Depart: 06.30; Start 07.00
12th Street Entrance (Lobby Level)
$25
Start the day with a run/walk by the scenic Boathouse Row
along the Schuylkill River. This will be a down and back flat
marked path with chipped timing. Everyone is invited to either
beat your best time or enjoy a casual walk along the river.
Proceeds benefit the Center for Information & Study on
Clinical Research Participation (CISCRP).
Sponsored by:
Tuesday, 10 November
08.00 – 10.00
Grand A-F (Level 5)
$45
Join ISPE leadership and colleagues for breakfast as we review
2015 and recognize significant achievements. Celebrate with
your colleagues as the 2015 Facility of the Year (FOYA) Overall
Winner and ISPE International Honor Awards are presented.
Joseph Famulare, Vice President – Global Quality Compliance
and External Collaboration, Genentech/Roche, Pharma
Technical Operations, ISPE Incoming Chair, 2015-2016
John Bournas, ISPE President and CEO
Presentation of the 2015 ISPE International Honor Awards
Jim Breen, VP Worldwide Engineering-Technical Operations,
Johnson & Johnson, 2015 Facility of the Year Judge’s Chair
Presentation of the 2015 Facility of the Year Award (FOYA)
2015 FOYA Awards Sponsored by:
Event Sponsored by:
Proceeds Benefits:
Tuesday Night Party at Reading Terminal Market
New Member and First-Time Attendee
Orientation and Networking Breakfast
Tuesday, 10 November
07.15 – 08.15
Independence I-III (Level 3 across bridge to
convention center)
Experience a taste of the Terminal with a wide variety of delicious
cuisines and Philadelphia favorites represented on the menu!
Reading Terminal is a 123-year-old historic building located right
in the heart of Philadelphia. Voted one of the top ten places to
visit in America, the Reading Terminal is one of the most exciting
places to visit because of its food and atmosphere! The night
will be full of networking and entertainment by the famous
Philadelphia Mummers. And, for the first time, get ready to rock
with ISPE’s very own member band!
Monday, 9 November
New to ISPE or to the Annual Meeting? This session will help
you make the most of your time at the conference. Veteran
ISPE Members will share their experiences and tips on
how to engineer a successful Annual Meeting experience.
Get a great start to your day with breakfast while you enjoy
one of our most popular events: Speed Networking. This is
your opportunity to quickly build your lifelong professional
network. Don’t forget your business cards!
CONNECT SHARE FOLLOW #ISPEAM15
18.45 – 22.00 (Meet in Hotel Lobby for a special performance)
$200
Party Sponsored By:
Party prizes sponsored by:
77
Facility Tours
Plus Philadelphia Excursions
Wednesday, 11 November 2015
Includes: transportation, tours and lunch. All tours depart from 12th Street Entrance (lobby level). Space is limited.
Times subject to change based on traffic and other factors.
Tour I
Tour III
SOLD OUT!
Merck’s Gardasil Vaccine Production Facility
09.00 – 16.00
$50
• Tour Independence Hall
• Tour Merck’s Gardasil Vaccine Production Facility
• Lunch (included)
• Tour of Valley Forge
Tour II
AstraZeneca’s Newark Facility
Transformation Project
09.40 – 20.00
$85
• Tour Independence Hall
• Tour AstraZeneca’s New Formulation Suite
• Lunch (included)
• Tour Longwood Gardens
• Dinner at Victory Brewery (included)
Guidelines for Facility Tours
Morphotek’s 2013 Sustainability Facility of
the Year Category Winner
09.40 – 20.00
$85
• Tour Independence Hall
• Tour Morphotek’s Sustainable Facility of the Year
• Lunch (included)
• Tour Longwood Gardens
• Dinner at Victory Brewery (included)
• Participants must wear closed toe and closed heel shoes.
• It is recommended that participants wear comfortable shoes with a low or flat heel.
• Recording or transmitting images from cameras, cell phones or other devices is not permitted on the site.
• Any personal medication or food should not be carried on persons while touring the facility.
• Must have valid personal identification for plant access (e.g. driver license, passport).
• Must arrive and leave by ISPE bus. No individual
walk-ins permitted.
Sponsored by:
Merck Tour Bus Sponsor
Independence Hall Tour
78
ISPE Annual Meeting 2015
Longwood Gardens Tour
and Dinner
AstraZeneca Tour Bus Sponsor
REGISTER NOW!
ISPE 2016
Annual Meeting
and Expo
Atlanta, Georgia
18–21 September | Marriott Marquis
Save $100 with On-Site Registration!
Details Available at ISPE Booth
Connecting a World of
Pharmaceutical Knowledge
Affiliate/Chapter
Council Information
Sunday, 8 November
Joint Affiliate Council Meeting
08.30 – 14.30
Grand H (Level 5)
Opening Keynote Session
15.00 – 17.00
Grand A-F (Level 5)
Welcome Reception in the Exhibit Hall
17.00 – 19.00
Franklin Hall (Level 4)
Monday, 9 November
Affiliate/Chapter Managers Meeting
09.00 – 11.00
302 (Level 3)
North America/South America Affiliates
Council Meeting
13.30 – 15.30
Independence I-III (Level 3 across bridge to
convention center)
Lunch in the Exhibit Hall
12.15 – 13.30
Franklin Hall (Level 4)
ISPE Training Institute, Tampa, FL
• GAMP® 5 Data Integrity (T50)
• Basic GAMP, Annex 11 / Part 11 (T45)
FEBRUARY
ISPE Training Institute, Tampa, FL
• Auditing (G07)
• Bio Manufacturing (T31)
• Bio Process Validation (T32)
• C&Q (T40)
• GAMP® 5 Process Control (T21)
• HVAC (T14)
• Process Validation (T46)
• Technology Transfer (T19)
MARCH
ISPE Training Institute, Tampa, FL
• Application of GAMP® 5 (T11)
• Cleaning Validation (T17)
• Facilities, Systems and Equipment Workshop (T48)
• QRM (T42)
APRIL
California
• Basic GAMP® 5, Annex 11 / Part 11 (T45)
• Bio Manufacturing Processes (T24)
• Facility Project Management* (T26)
• OSD (T10)
• Water Generation, Storage, Delivery
and Qualification (T04 and T23)
Global Regulatory Town Hall
16.00 –17.30
Grand A-F (Level 5)
Manchester, UK
Mix and Mingle Reception in the Exhibit Hall
17.30 – 18.30
Franklin Hall (Level 4)
MAY
Tuesday, 10 November
Membership Breakfast and Awards Ceremony
08.00 – 10.00
Grand A-F (Level 5)
Asia-Pacific Affiliates Council Meeting
10.30 – 11.30
307 (Level 3)
Membership Development Committee
15.30 – 17.00
403 (Level 4)
Tuesday Night Party
18.45 – 22.00
Reading Terminal Market
(Off-property – meet in the hotel lobby)
80
JANUARY
ISPE Annual Meeting 2015
• GAMP® 5 Data Integrity (T50)
ISPE Training Institute, Tampa, FL
• C&Q (T40)
• GAMP® 5 Data Integrity (T50)
• Cross Contamination (T41)
• QbD (T43)
Brussels, Belgium
• Basic GAMP® 5, Annex 11 / Part 11 (T45)
• Bio Manufacturing (T31)
• Cleaning Validation (T17)
• C&Q (T40)
• Process Validation (T46)
• Project Management* (T26)
JUNE
ISPE Training Institute, Tampa, FL
• Auditing (G07)
• Bio Process Validation (T32)
• Sterile (T12)
• Q7A (T30)
Visit www.Training@ISPE.org
Life Sciences Industry is Moving to the Cloud
Veeva Systems
4280 Hacienda Drive
Pleasanton, CA 94588
Email: info@veeva.com
Phone: +1 925 452 6500
Fax: +1 925 452 6504
www.veeva.com
The end-to-end development of a product now involves a more complex network of partners—a shift
with significant implications for quality. The growth of outsourcing makes it difficult to manage and
control content for external users, ultimately impacting quality and compliance. Companies also need
to prepare for more rigorous reporting requirements as health authorities increase scrutiny into the
quality of manufacturing.
Solutions that allow seamless collaboration with external partners, increases visibility, and enable
organizations to easily adapt to new requirements while assuring compliance are essential to success.
The emergence of secure, scalable cloud applications now presents the opportunity for life sciences
organizations to maintain compliance in a highly regulated environment while benefiting from many
of the same advantages that were only available in other industries.
Advantages of Regulated Content Management in the Cloud
Auditors use documentation to help assess the quality of company and site operations, as well as the final manufactured product.
As the industry’s reliance on external partners grows, many organizations struggle to remain compliant. To streamline quality processes
and reduce risk, all parties need to collaborate on documents, within a single, secure system. However, providing external users direct
access to key applications and information cannot come at the expense of maintaining control.
Applications tailored to life sciences and delivered securely in the cloud bring together businesses, partners, and customers. They allow
all parties to participate in critical processes, while enabling companies to retain complete oversight.
Benefits of Cloud
• A Foundation for Information Sharing and Collaboration
Internal users, partners, and other systems all connect and
communicate in the cloud, simplifying end-to-end quality
processes.
• Accelerates Validation
Designed with rigorous requirements in mind, these applications undergo IQ and OQ validation and provide tools to
accelerate and simplify validation.
• Increases Visibility
Companies are empowered to make proactive, informed decisions with insightful reports and dashboards, and demonstrate
compliance with detailed audit trails.
• Instant Scalability
With cloud’s elastic architecture, organizations can easily
scale with more users, content, or usage.
• Drives Greater User Adoption
Intuitively designed and easily accessible—anytime, anywhere, and from any device—cloud-based applications help
organizations achieve greater user adoption, minimizing work
outside of the system.
• Strengthens Compliance
Applications for life sciences are developed to address global
regulations, support emerging regulatory trends, and include
core compliance features such as change control, electronic
signatures, read and understood, and more.
• Enhances Process Efficiency
Flexible content workflows align with business processes,
making them more efficient.
Veeva Vault QualityDocs is a cloud-based content management
application that offers document control, superior ease-of-use,
and secure access for all users. Built for life sciences, Vault
QualityDocs improves quality documentation processes and
minimizes compliance risk.
About Us
Veeva Systems Inc. is a leader in cloud-based software for the
global life sciences industry. Committed to innovation, product
excellence, and customer success, Veeva has more than 200
customers, ranging from the world’s largest pharmaceutical
and medical device companies to emerging biotechs. Veeva
is headquartered in the San Francisco Bay Area, with offices
in Europe, Asia, and Latin America.
ISPE Conferences
ISPE Quality Manufacturing
Conference
ISPE Aseptic Conference
29 February – 1 March
Crystal City, VA
ISPE Europe Annual
7 – 9 March
Frankfurt, Germany
Meeting
ISPE China Spring Conference
19 – 21 April
ISPE Continuous Manufacturing
Conference
May
Bethesda, MD
ISPE Quality
5 – 6 June
Bethesda, MD
Metrics Conference
6 – 8 June
Bethesda, MD
ISPE Annual Meeting
18 – 21 September
Atlanta, GA
ISPE
Process Validation/
PV Stats Conference
October
Bethesda, MD
Pharma EXPO 2016
6 – 9 November
Chicago, IL
ISPE Biopharmaceutical
Manufacturing Conference
December
www.ISPE.org/Events
Thank You to Our Sponsors
84
PINNACLE SPONSOR
PINNACLE SPONSOR
PINNACLE SPONSOR
Badge Sponsor
Independence Hall Tour Sponsor
Keynote Speaker Sponsor
Lanyard Sponsor
Wireless Internet Sponsor
Leadership Reception Sponsor
Tote Bag Insert Sponsor
Host Sponsor
Supporting Sponsor
Gold Sponsor
Leadership Reception Sponsor
Silver Sponsor
2015 FOYA Marquee Sponsor
Tuesday Night Party Sponsor
Silver Sponsor
Exhibit Hall Giveaway Sponsor
Silver Sponsor
Exhibit Hall Giveaway Sponsor
Membership Breakfast Sponsor
ISPE Annual Meeting 2015
Refreshment Sponsor
Mobile Charging Station
Sponsor
Charity 5k Run/Walk
Sponsor
Lunch Sponsor
Longwood Gardens Tour
and Dinner Sponsor
Merck Tour Bus Sponsor
Exhibit Hall Giveaway
Sponsor
Data Integrity, Special
Topic Session Sponsor
AstraZeneca Tour Bus
Sponsor
Exhibit Hall Giveaway
Sponsor
Hotel Key Card Sponsor
Exhibit Hall Giveaway
Sponsor
Tuesday Night Party Prize
Sponsor
Lunch Sponsor
Membership Breakfast Sponsor
Welcome Reception Sponsor
Exhibit Hall Giveaway
Sponsor
Exhibit Hall Giveaway
Sponsor
delivering excellence
Poster Competition Sponsor
Exhibit Hall Giveaway
Sponsor
Tote Bag/Insert Sponsor
Tote Bag Sponsor
Exhibit Hall Giveaway
Sponsor
Exhibit Hall Giveaway Sponsor
CONNECT SHARE FOLLOW #ISPEAM15
Welcome Reception
Sponsor
Membership Breakfast Sponsor
85
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Exchanging Ideas
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NNE Pharmaplan understands what
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86
ISPE Annual Meeting 2015
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or identifying solutions for increasing
cost-effectiveness, we can help you
develop the agility you need to
overcome today’s challenges.
Learn more at nnepharmaplan.com
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ON COMPLIANCE QUALITY PROCESS & CLEANING VALIDATION SARBANES-OXLEY SERVICES TRAINING INFRASTRUCTURE TECHNOLOGY COMPUTER SYSTEMS VALIDATION IT/IM QUALITY & COMPLIANCE IT TRAINING PHARMACEUTICA
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NCE PREVENTATIVE MAINTENANCE TECHNICAL STAFFING CONTRACT STAFFING CONTRACT-TO-HIRE DIRECT PLACEMENTSTRATEGY EXECUTION CONSULTING COMMISSIONING,VERIFICATION/QUALIFICATION & VALIDATION COMPUTE
ON COMPLIANCE QUALITY PROCESS & CLEANING VALIDATION SARBANES-OXLEY SERVICES TRAINING INFRASTRUCTURE TECHNOLOGY COMPUTER SYSTEMS VALIDATION IT/IM QUALITY & COMPLIANCE IT TRAINING PHARMACEUTICA
DEVICE TESTING FOOD TESTING COSMETICS TESTING PROCESS ENGINEERING CONTROLS & AUTOMATION CALIBRATION CERTIFICATION CHAMBER MAINTENANCE PREVENTATIVE MAINTENANCE TECHNICAL STAFFING CONTRACT
-TO-HIRE DIRECT PLACEMENT STRATEGY EXECUTION CONSULTING COMMISSIONING,VERIFICATION/QUALIFICATION & VALIDATION COMPUTER SYSTEM VALIDATION COMPLIANCE QUALITY PROCESS & CLEANING VALIDATION SARBAN
TRAINING INFRASTRUCTURE TECHNOLOGY COMPUTER SYSTEMS VALIDATION IT/IM QUALITY & COMPLIANCE IT TRAINING PHARMACEUTICAL TESTING MEDICAL DEVICE TESTING FOOD TESTING COSMETICS TESTING PROCESS ENG
& AUTOMATION CALIBRATION CERTIFICATION CHAMBER MAINTENANCE PREVENTATIVE MAINTENANCE TECHNICAL STAFFING CONTRACT STAFFING CONTRACT-TO-HIRE DIRECT PLACEMENT STRATEGY EXECUTION CO
ONING,VERIFICATION/QUALIFICATION & VALIDATION COMPUTER SYSTEM VALIDATION COMPLIANCE QUALITY PROCESS & CLEANING VALIDATION SARBANES-OXLEY SERVICES TRAINING INFRASTRUCTURE TECHNOLOGY COMPUTER
ON IT/IM QUALITY & COMPLIANCE IT TRAINING PHARMACEUTICAL TESTING MEDICAL DEVICE TESTING FOOD TESTING COSMETICS TESTING PROCESS ENGINEERING CONTROLS & AUTOMATION CALIBRATION CERTIFICATION
NCE PREVENTATIVE MAINTENANCE TECHNICAL STAFFING CONTRACT STAFFING CONTRACT-TO-HIRE DIRECT PLACEMENT STRATEGY EXECUTION CONSULTING COMMISSIONING,VERIFICATION/QUALIFICATION & VALIDATION COMPUTE
ON COMPLIANCE QUALITY PROCESS & CLEANING VALIDATION SARBANES-OXLEY SERVICES TRAINING INFRASTRUCTURE TECHNOLOGY COMPUTER SYSTEMS VALIDATION IT/IM QUALITY & COMPLIANCE IT TRAINING PHARMACEUTICA
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SOUTHEAST
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Mark O’Donnell: Ext. 513
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AZZUR.COM | 1.800.726.0331
87
East Montgomery County
Industrial Park
500 acre Industrial Park near Houston, TX
3 minutes to the Grand Parkway (SH 99)
15 minutes to Bush Intercontinental Airport
30 minutes to the Port of Houston
Financial incentives available to help
make your expansion dreams a reality!
ST MONTGO
ME
NTY IMP
V
S
XA
ME
TE
GO
NT
EA
MO
Come see us in Booth #222
RO
RY C O U N T
Y,
T DISTRICT
281.354.4419
COU
EN
www.emctx .com
RY
EM
East Montgomery County Improvement District
New Caney, TX
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ISPE Annual Meeting 2015