ISPE/FDA/PQRI
Quality Manufacturing
Conference
1 – 3 June 2015
The Mayflower Renaissance • Washington, DC
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When change
is the only
constant,
are your facilities
up to speed?
Sites today have to be agile in order to deliver on
unexpected targets and respond rapidly to changes
In the new pharma reality, agility
makes the difference between
success and failure. The ability of
pharma facilities to rapidly implement
new technology, react to changing
production demands and answer
cost pressures is key not only to their
success, but also to their survival.
NNE Pharmaplan understands what
it takes to keep your pharma facility
competitive in an ever-changing
industry where scalability, flexibility
and regulatory compliance are the
most important drivers. Whether
2 implementing new technologies,
enabling multiproduct manufacturing
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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Conference Code: ispe15
Keynote
Sessions
Monday, 1 June 2015
08.30 – 10.15 • State Room
Special
Sessions
Quality Metrics
Monday, 1 June 2015
11.00 – 12.30, State Room
Hear a report on the ISPE Quality Metrics
Summit and discuss next steps for Quality
Metrics.
Breakfast with the Investigators
Tuesday, 2 June 2015
07.30 – 08.45, State Room
FDA Quality Initiatives
Back by popular demand! Hear what FDA’s
front-line investigators have to say.
Janet Woodcock, MD,
Director, FDA/CDER
Understanding Changes at FDA
Wednesday, 3 June 2015
13.00 – 15.30, State Room
Innovative Manufacturing
Promotes Quality
Juan Andres, Head Global Novartis Tech
Ops, Novartis Pharma AG
Learn about the reorganization at FDA and
get a better understanding of the changes.
All submitted presentation handouts
are available for registered delegates
through the conference homepage.
Tuesday, 2 June 2015
09.00 – 10.00 • State Room
Supply Chain Risk
Management
Andrew Skibo, Head of Global Biologics
Operations and Real Estate, MedImmune/
AstraZeneca
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Facility of the Year
Awards Reception
and Banquet
Tuesday, 2 June 2015
18.30 – 22.30, Grand Ballroom
Join ISPE and prominent industry leaders as we
recognize the 2015 Category Winners for their
innovation and creativity in pharmaceutical and
biotechnology facility design, construction and
operation. Individual tickets are available at
registration for $155.
ISPE/FDA/PQRI Quality Manufacturing Conference 3
Monday, 1 June 2015
08.30 – 10.15
Keynote Session
State Room (Lobby Level)
ISPE Welcome with John Bournas, ISPE President and CEO
Welcome and Opening Remarks from Industry Co-Chair
Joe Famulare, VP, Global Compliance and External Collaboration, Pharma Technical Quality,
Genentech (A Member of the Roche Group)
FDA Quality Initiatives
Janet Woodcock, MD, Director, FDA/CDER
Innovative Manufacturing Promotes Quality
Juan Andres, Head Global Novartis Technical Operations, Novartis Pharma AG
10.15 – 11.00
Networking Break
Foyer (Lobby Level)
11.00 – 12.30
Update on Quality Metrics and Panel Discussion
State Room
Moderator: Joe Famulare, Genentech (A Member of the Roche Group)
Panelists: Tara Gooen Bizjak, Senior Science Policy Advisor, FDA/CDER/OPQ, Invited; Diane Hagerty, Vice
President, Genentech (A Member of the Roche Group); Chris Potter, PhD, CMC Pharmaceutical Consultant
and ISPE Advisor
12.30 – 13.30
Lunch in the Exhibit Hall
Grand Ballroom (Lobby Level)
13.30 – 15.00
EDUCATION SESSIONS
Modernization in
Manufacturing
Regulatory Insights
Quality Systems
Continuous Manufacturing
Process Capability
Corporate Responsibility
for Quality
Cabinet Room (Lobby Level)
State Room (Lobby Level)
Senate Room (Lobby Level)
Moderator: Dora Kourti, PhD,
Senior Technical Director,
GlaxoSmithKline
PAT – 15 Years Later
Dora Kourti, PhD,
Senior Technical Director,
GlaxoSmithKline
A Regulatory Perspective on
Continuous Manufacturing of
Pharmaceuticals
Rapti Madurawe, PhD,
Supervisory Chemist, FDA/
CDER/OPQ/OPF/DPAI/PAB
Continuous Pharmaceutical
Manufacturing: Quality-byDesign, Systems Integration,
and Control
Richard Braatz, PhD, Professor
of Chemical Engineering,
Novartis-MIT Center for
Continuous Manufacturing
4 ISPE/FDA/PQRI Quality Manufacturing Conference
Moderator: Peter Millili, PhD,
Principal Engineer, Bristol-Myers
Squibb
Moderator: Rick Friedman, Deputy
Director, Science and Regulatory
Policy, Office of Manufacturing
Get Up and Dance: Launching Quality, FDA/CDER/OC/OMQ
a Process Capability Program
Corporate Governance in the
in a Global Manufacturing
21st Century
Network
Greg Williams, Global Head of
Aaron Goerke, PhD, GBMSAT
Purification Senior Group Leader, Audit, Novartis Pharmaceuticals
Genentech (A Member of the
The Executive Role: Overseeing
Roche Group)
Applications of Process
Capability in Technology
Transfer
Both System and Process
Health
Peter Millili, PhD, Principal
Engineer, Bristol-Myers Squibb
Johna Norton, Vice President,
Quality, Global API, Puerto Rico,
and Product Research and
Development, Eli Lilly & Co.
Continual Improvement-Cpks
in Action
Business Across Borders: The
Impact of Culture on Quality
Georgina McLeod, Principle
Process Development Engineer,
AbbVie
Dana Blobner, Director
Quality Assurance, Ultragenyx
Pharmaceutical Inc.
15.00 – 16.00
Networking Break in the Exhibit Hall
Grand Ballroom
16.00 – 17.30
EDUCATION SESSIONS
Modernization in
Manufacturing
Regulatory Insights
Quality Systems
Continuous Manufacturing
Monitoring and Reducing
Variability During the PV
Lifecycle
Using Operational Excellence
as a Foundation for Quality
Cabinet Room (Lobby Level)
State Room (Lobby Level)
Senate Room (Lobby Level)
Moderator: Dora Kourti, PhD,
Senior Technical Director,
GlaxoSmithKline
Changing the Pharmaceutical
Industry Paradigm: Portable,
Continuous, Miniature and
Modular Approach
Phil Nixon, PhD, Executive
Director at Pfizer – Advanced
External Projects, Pfizer Inc.
Delivering Breakthrough
Therapies to the Market with
Continuous Manufacturing
and Real Time Release
Hayden Thomas, Vice President,
Formulation Development, Vertex
Pharmaceuticals
Moderator: Joanne Barrick, RPh,
Advisor, Global Validation,
Eli Lilly & Co.
Progress with Implementation
of the Lifecycle Approach to
PV: Summary of Stats in PV
Forum
Tara Scherder, Managing
Director, Arlenda Inc.
Driving Process Performance
through Awareness and
Proactive Response
Moderator: Stephen Tyler, Director
Quality Assurance, AbbVie
Insights from 10 Years of
Research
Thomas Friedli, Vice Director,
Institute of Technology
Management, University of
St. Gallen (Switzerland)
An Operational Excellence
Thinking Model
Mark Swatling, Senior Director
of Operational Excellence,
AstraZeneca
Jenn Walsh, Associate Director
Technical Services, Bristol-Myers FDA Perspective
FDA Representative
Squibb
Variation is the Enemy: Practical
Tools for Identifying and
Reducing In-Process Variation
How to Achieve Operational
Excellence by Continuous
Mike Reske, Quality Engineering
Processing. The Implementation Manager, Perrigo Company PLC
of Continuous Manufacturing
in the Pharmaceutical Industry Product and Process
Robustness
Richard Steiner, GEA Pharma
Systems
17.30 – 19.00
Daniel Peng, PhD,
Senior Product Quality Reviewer,
FDA/CDER/OPQ/OPF
Networking Reception in the Exhibit Hall
Grand Ballroom
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ISPE/FDA/PQRI Quality Manufacturing Conference 5
Tuesday, 2 June 2015
07.30 – 08.45
Breakfast with the Investigators
State Room
Moderator: Milind Ganjawala, Branch Chief, Office of Manufacturing Quality, FDA/CDER/OC/OMQ
Panelists: Jonathan Chapman, Consumer Safety Officer, FDA/ORA/OGROP; Brooke Higgins, Senior
Policy Advisor, FDA/CDER/OC/OMQ
09.00 – 10.00
Keynote Session
State Room
Welcome and Opening Remarks from FDA Co-Chair
Christine Moore, PhD, Acting Director, Office of Process and Facilities, FDA/CDER/OPQ/OPF
Supply Chain Risk Management
Andy Skibo, Head of Global Biologics Operations and Real Estate, MedImmune/AstraZeneca
10.00 – 10.45
Networking Break in the Exhibit Hall
Grand Ballroom
10.45 – 12.00
EDUCATION SESSIONS
Modernization in
Manufacturing
Regulatory Insights
Colonial Room (Lower Level)
Quality Systems
State Room (Lobby Level)
Senate Room (Lobby Level)
Modernization and
Risk Management
Production Efficiency: Key Moderator: Chuck Hoiberg, PhD,
Elements in Drug Shortage Executive Director, Pfizer Inc.
Prevention
Moderator: Lorraine McClain,
Senior Director, Quality
Risk Management, Teva
Pharmaceuticals
Moderator: Frances Zipp,
President, Lachman Consultant
Services Inc. and ISPE Drug
Shortages Steering Committee
Member
Highlights of ISPE/FDA
QRM Workshop on Product/
Process Development
Drug Shortage Team Update
How OPF Utilizes Risk
Assessment during Application When Change is Imperative
Review
Cathy Burgess, Partner, Alston &
Frances Zipp, President,
Lachman Consultant Services
Inc. and ISPE Drug Shortages
Steering Committee Member
Preventing Drug Shortages–
FDA’s and Manufacturers’
Roles
Capt. Val Jensen, RPh,
Associate Director, Drug
Shortage Staff, FDA/CDER/OCD/
DSS
Panel Discussion with the
ISPE Drug Shortages Team
12.00 – 13.00
Robust Change Management
Lunch in the Exhibit Hall
Grand Ballroom
6 ISPE/FDA/PQRI Quality Manufacturing Conference
Vince McCurdy, PhD, Head
Operational Excellence,
Pfizer Inc.
Naiqi Ya, PhD, Supervisory
Chemist, FDA/CDER/OPQ/OPF/
DPAII
Across the Lifecycle
Nigel Hamilton, Head of Global
Quality External Affairs, Global
Quality Strategy and Systems,
Sanofi
Bird LLP
Panel Discussion with Session
Speakers
Moderated by Mary Oates, PhD,
VP, Global Quality Operations,
Pfizer Inc.
13.00 – 14.30
EDUCATION SESSIONS
Modernization in
Manufacturing
Regulatory Insights
Quality Systems
Modernization of Legacy
Facilities
Breakthrough Therapy
Compliance and
Enforcement
Colonial Room (Lower Level)
State Room (Lobby Level)
Senate Room (Lobby Level)
Moderator: Lance Minor,
Vice President of Operations
Strategy & Network
Performance, MedImmune/
AstraZeneca
Moderator: Eric Thostesen,
Senior Director, Regulatory
Compliance, Janssen
Pharmaceutical Company Inc.
Moderator: Lorraine McClain,
Senior Director, Quality
Risk Management, Teva
Pharmaceuticals
Advancing Risk Management
Concepts in Accelerated Drug What is “Compliance”? Some
Common Misconceptions
Manufacturing Modernization: Applications
Rick Friedman, Deputy Director,
Eric
Thostesen,
Senior
Director,
Old Facilities + New Tech
Science and Regulatory Policy,
Dave Marks, Principle, DME
Engineering
Maintaining Your
Manufacturing Facilities in
“Current” State (Case
Studies)
Younok Dumortier Shin,
Director, Large Molecule
Technology, Janssen
Pharmaceutical Company Inc.
Vertical Integration of
Disposables in
Biopharmaceutical
Manufacturing
Sigma S. Mostafa, PhD,
Director, Process Development,
KBI Biopharma, Inc.
14.30 – 15.30
Regulatory Compliance, Janssen
Pharmaceutical Company Inc.
Accelerated Development
Quality Management System
Application and Deferrals
Strategy
Kate Waters, Principal Engineer,
Genentech (A Member of the
Roche Group)
FDA Perspective on
Breakthrough Therapies
David Doleski, Deputy Director
(Acting), Office of Process and
Facilities, FDA/CDER/OPQ/OPF;
Dorota Matecka, Chemist,
FDA/CDER/OPQ/ONDQ
Office of Manufacturing Quality,
FDA/CDER/OC/OMQ
The Drift Towards
Non-Compliance
Veronica Cruz, PhD, Executive
VP/COO, ReComS Group
Product Tracing and
Identification Under the Drug
Supply Chain Security Act
Connie Jung, Pharmacologist,
FDA/CDER/OC/ODSIR
Networking Break in the Exhibit Hall
Grand Ballroom
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ISPE/FDA/PQRI Quality Manufacturing Conference 7
15.30 – 17.00
Education Sessions
Modernization in
Manufacturing
Regulatory Insights
Quality Systems
Advanced Applications for
Contamination Control –
Drug Substance and Drug
Product
Lifecycle Knowledge
Management
Lifecycle Data Integrity
Colonial Room (Lower Level)
State Room (Lobby Level)
Senate Room (Lobby Level)
Moderator: Paul Smock,
Biotechnology Quality &
Technical Consultant, Meridan
BioGroup
Closed Systems: Risk
Mitigation for Contamination
Control and Product Quality
Paul Smock, Biotechnology
Quality & Technical Consultant,
Meridan BioGroup
Engineering HTST Skids
Marcella Goodnight, Associate
Director, Process Engineering,
Global Technical Operations,
AstraZeneca/MedImmune
Application of Closed
Processing in Contamination
Control
Moderator: Paige Kane,
Director of Knowledge
Management, Pfizer Global
Supply
Managing What We Know - A
Lifecycle Approach
Paige Kane, Director of
Knowledge Management, Pfizer
Global Supply; Nuala Calnan,
PhD, Regulatory Science
Researcher, ISPE Quality Culture
Team Lead, Dublin Institute of
Technology
Knowledge and Risk-Based
Strategies for Lifecycle
Management: An FDA
Perspective
Christina Capacci-Daniel,
Consumer Safety Officer,
FDA/CDER/OPQ/OPF/DIA/IABI
Robert Boulanger, PhD,
Process Specialist, CRB
Aseptic Processing
Contamination Control:
Microorganisms and
Macro-particulates
Steve Langille, PhD, Acting
Branch Chief – Office of
Process and Facilities –
Division of Microbiology
Assessment, FDA
18.30 – 22.30
Facility of the Year Awards Reception and Banquet
Grand Ballroom
Join ISPE to honor the 2015 Category Winners.
Individual tickets are available at registration for $155.
8 ISPE/FDA/PQRI Quality Manufacturing Conference
Moderator: Stephen Tyler,
Director Quality Assurance,
AbbVie
Business Reliability Built Upon
Data Integrity
David Perkins, Director, Quality
& Compliance, AbbVie
FDA’s Perspective and
Current Findings on Data
Integrity
Karen Takahashi, Consumer
Safety Officer, FDA/CDER/OPQ/
OPPQ/DRGS/CO
Holistic Approach to
Strengthen Data Integrity
Peter Carbone, Vice President,
Global Head External Relations,
Group Quality Novartis Services,
Inc.
Panel Discussion with Session
Speakers
Moderated by Elaine Eborall,
Senior Director, Genentech (A
Member of the Roche Group)
Wednesday, 3 June 2015
All Regulatory Insights sessions are located in the State Room unless otherwise noted.
09.00 – 10.30
Welcome and Opening Remarks
Tom Cosgrove, JD, Director, Office of Manufacturing Quality, Office of Compliance, FDA
Global Harmonization
Moderator: Steve Mahoney, Senior Director, Global Quality & Compliance, Genentech
(A Member of the Roche Group)
Q7 – Alicia Mozzachio, RPh, Director, Regulatory, FDA/CDER/OPQ/OPPQ/DRGS
ICH Q11 Starting Material Update – Tim Watson, PhD, Research Fellow/CMC Advisory Office,
Pfizer Inc.
10.30 – 11.00
Q12 – Mary Oates, PhD, VP, Global Quality Operations, Pfizer Inc.
Networking Break
Foyer
11.00 – 12.00
International Regulatory Perspective
Moderator: Louis Yu, PhD, Executive Vice President, Perrigo
Inspection Trends and Enforcement: EU Perspective
Gerald Heddell, Director, Inspection Enforcement and Standards Division, MHRA, United Kingdom
12.00 – 13.00
Lunch
Grand Ballroom
13.00 – 15.30
Understanding the Changes at the FDA
Moderator: Giuseppe Randazzo, Director, CDER/OND/ODEIII
Reorganization Overview
Cynthia Schnedar, JD, Director, Office of Compliance, FDA/CDER/OC
Office of Manufacturing Quality
Tom Cosgrove, JD, Director, Office of Manufacturing Quality, FDA/CDER/OC/OMQ
Office of Pharmaceutical Quality
Christine Moore, PhD, Acting Director, Office of Process and Facilities, FDA/CDER/OPQ/OPF
Office of Regulatory Affairs
Thomas Arista, Consumer Safety Officer, Southwest Regional Field Office,FDA/ORA/OO, Invited
Panel Discussion with Session Speakers
Rick Friedman, Deputy Director, Science and Regulatory Policy, Office of Manufacturing Quality,
FDA/CDER/OC/OMQ; Mahesh Ramanadham, PharmD, Regulatory Operations Officer,
FDA/CDER/OPQ/OPF/DIA/IABI; Francis Godwin, Division Director, Division of Drug Quality 2 (DDQ2),
FDA/CDER/OC/OMQ
15.30 – 16.00
Question-Answer Opportunity and Closing Remarks
Joe Famulare, VP, Global Compliance and External Collaboration, Pharma Technical Quality, Genentech
(A Member of the Roche Group)
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ISPE/FDA/PQRI Quality Manufacturing Conference 9
Exhibit Hall Map
and Event Schedule
F&B
F&B
F&B
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46
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14 17
20 23
26 29
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38
1
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13 18
19 24
25 30
31 36
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EXIT
EXIT
ENTER
REGISTRATION
Monday, 1 June 2015
07.00 – 17.30
Registration Open Foyer
08.30 – 10.15 Keynote Session State Room
10.15 – 11.00
Networking Break Foyer
11.00 – 12.30 Quality Metrics
State Room
12.00 – 19.00
Exhibit Hall Open Grand Ballroom
12.30 – 13.30 Lunch in Exhibit Hall
Grand Ballroom
13.30 – 15.00 Education Sessions (3 Tracks)
Senate, Cabinet and State Rooms
15.00 – 16.00 Networking Break in Exhibit Hall
Grand Ballroom
16.00 – 17.30 Education Sessions (3 Tracks)
Senate, Cabinet and State Rooms
17.30 – 19.00 Networking Reception Grand Ballroom
Tuesday, 2 June 2015
07.00 – 19.30
Registration Open Foyer
07.30 – 08.45 Breakfast with the Investigators State Room
09.00 – 10.00 Keynote Session State Room
09.30 – 15.30
Exhibit Hall Open Grand Ballroom
10.00 – 10.45 Networking Break in Exhibit Hall Grand Ballroom
10.45 – 12.00 Education Sessions (3 Tracks)
Senate, Colonial and State Rooms
12.00 – 13.00 Lunch in Exhibit Hall Grand Ballroom
13.00 – 14.30 Education Sessions (3 Tracks)
Senate, Colonial and State Rooms
14.30 – 15.30 Networking Break in Exhibit Hall Grand Ballroom
15.30 – 17.00 Education Sessions (3 Tracks)
Senate, Colonial and State Rooms
18.30 – 22.30 FOYA Reception and Banquet Grand Ballroom
Wednesday, 3 June 2015
07.00 – 15.00
Registration Open Foyer
09.00 – 10.30 Regulatory Session State Room
10.30 – 11.00 Networking Break
Foyer
11.00 – 12.00 Regulatory Sessions
State Room
12.00 – 13.00 Lunch
Grand Ballroom
13.00 – 16.00 Regulatory Session State Room
*All education rooms and the exhibit hall are located on
the Lobby and Lower Levels.
10 ISPE/FDA/PQRI Quality Manufacturing Conference
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
Exhibitor Directory
Agilent Technologies
Table #12
2850 Centerville Road
Wilmington, DE 19808 USA
Tel: +1-302-332-6720
www.agilent.com/chem
Contact: Danielle Ballard
danielle_ballard@agilent.com
Agilent manufactures and distributes a
complete line of instrumentation
serving many lab markets including
clinical, analytical, environmental,
pharma, forensic science and
academia.
Azzur Group
Table #25
7310 Grove Road, Suite 105
Frederick, MD 21704 USA
Tel: +1-800-726-0331
www.azzur.com
Contact: Nate Roman
nate.roman@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. From Discovery to Delivery,”
whatever you need, we can do.
Bausch + Stroebel
Machine Company, Inc.
Table #37
21 Commerce Drive
North Branford, CT 06471 USA
Tel: +1-203-484-9933
Fax: +1-203-484-9939
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, starting
from applications for laboratory testing
and clinical batches to fully integrated
commercial production.
BIOVIA
Table #17
66 York Street
Jersey City, NJ 07302 USA
Tel: +1-973-805-8600
www.qumas.com
Contact: Michael McGovern
info@qumas.com
BIOVIA from Dassault Systèmes is the
leader in Compliance and Quality
Management Solutions with more than
270 global customer deployments and
domain expertise in regulatory
compliance.
Caliber Infosolutions, Inc.
Table #36
1701 McFarland Rd., Suite 200
Pittsburgh, PA 15216-1812 USA
Tel: +1-888-510-LIMS
www.caliberinfosolutions.com
Contact: Nancy Espinal
nespinal@caliberuniversal.com
12 ISPE/FDA/PQRI Quality Manufacturing Conference
Caliber InfoSolutions Inc a software
products company, specialized in GMP
solutions for Manufacturing.
CaliberBRM, Electronic Batch Records
Management system is an award
winning enterprise grade software, built
on S88 S85 standards with 21 CFR Part
11 compliance. Let’s talk come by our
table.
Commissioning Agents
Inc.
Table #30
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.
CRB
Table #29
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 design, construction,
and consulting firm that relentlessly
pursues and delivers success for our
clients in advanced technology
industries. Founded in 1984 as a single
three-person office, we have grown to
a team of more than 700+ passionate
professionals in 14 offices throughout
the country. CRB’s single-minded focus
on putting our clients’ interests first every day, on every project - defines
us as a firm.
DME Alliance Engineering
Consultants
Table #32
7540 Windsor Drive Suite 311
Allentown, PA 18195 USA
Tel: +1-610-366-1744
Fax: +1-610-366-1784
www.dmealliance.com
Contact: Mark Matson
mmatson@dmealliance.com
DME Alliance Engineering Consultants
specializes in process facility design
for research & manufacturing plants in
the regulated life sciences - biotech,
pharmaceutical and medical devices.
Garvey, an innovative manufacturer of
vial handling and drying equipment,
specializes in accumulating, single
filing, and tray loading sterile
pharmaceutical goods.
Genesis Packaging
Technologies
Table #20
Building 1, 4th Floor
Red Bank, NJ 07701 USA
Tel: +1-732-945-0186
www.formpipegxp.com
Contact: 331 Newman Springs Rd.
info@formpipegxp.com
Formpipe.GxP, the Life Science
division of Formpipe Software AB,
simplify complex process and
technology environments to help Life
Science organisations achieve their
compliance goals. We achieve this
through a combination of EQMS
Solutions and Compliance
Consultancy that enable our
customers to ‘Get Compliant’ and
‘Stay Compliant’.
Garvey Corporation
Table #23
208 S. Route 73
Blue Anchor, NJ 08037 USA
Tel: +1-800-257-8581
Fax: +1-609-561-2450
www.garvey.com
Contact: Thomas Garvey
tgarvey@garvey.com
IcGXP, Inc.
Table #18
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
ProPharma Group
Table #24
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: Hardip Dosange
Hardip.Dosange@ProPharmaGroup.com
ProPharma Group is an industry leader
serving the comprehensive
compliance needs of the
pharmaceutical, biotechnology, and
medical device industries.
Pharmaceutical, medical device,
biotech quality and compliance
consulting.
PTI - Packaging
Technologies & Inspection
Table #31
MSAT Solutions by
4Tune Engineering
Table #26
145 Main Street
Tuckahoe, NY 10707 USA
Tel: +1-914-337-2005
Fax: +1-914-337-8519
www.ptiusa.com
Contact: Michelle Wolf
m.wolf@ptiusa.com
Av. António Augusto de Aguiar 108, 4
Lisboa 1050-019 Portugal
Tel: +351 91 382 11 03
Fax: +351 21 606 27 88
www.msatsolutions.com
Contact: João Machado
jm@4tuneengineering.com
Services and products from
development to routine manufacturing.
Our proven track-record in biopharma
and pharma around the world enables
us to work in the entire product
Lifecycle.
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11911 Freedom Drive, Suite 600
Reston, VA 20190 USA
Tel: 571-612-3200 Fax: 703-243-8556
http://pharmaexpo.com/
Contact: Lori Wulf
expo@pmmi.org
Pharma EXPO heads to Las Vegas,
September 28 30, 2015, answering
the demand for a show focused on
solutions for the entire pharmaceutical
and biopharmaceutical lifecycle.
435 Creamery Way
Exton, PA 19341 USA
Tel: +1-610-458-4900
Fax: +1-610-458-4939
www.gen-techno.com
Contact: Vince Paolizzi
info@gen-techno.com
Genesis Packaging Technologies is a
leader in the science and technology
of pharmaceutical vial processing and
handling.
Formpipe.GxP
Table #11
Pharma EXPO
Table #42
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.
ISPE/FDA/PQRI Quality Manufacturing Conference 13
UL EduNeering
Table #35
202 Carnegie Center, Suite 301
Princeton, NJ 08540 USA
Tel: +1-609-627-5300
Fax: +1-609-627-5330
www.uleduneering.com
Contact: Scott Barnard
Scott.Barnard@ul.com
UL EduNeering develops
technology-driven solutions to help
organizations mitigate risks, improve
business performance and establish
qualification and training programs
through a proprietary, cloud-based
platform, ComplianceWire®.
Weiss Envirotronics
Table #38
3881 N. Greenbrooke Dr SE
Grand Rapids, MI 49512 USA
Tel: +1-919-616-2694
www.envirotronics.com
Contact: Mark Holland
mholland@envirotronics.com
ISPE Annual Meeting 2015
8 – 11 November
Philadelphia, PA, USA
New Paradigms for
Manufacturing Excellence
• Contribute to robust supply
networks
• Advance production quality
• Prevent drug shortages
Register Now!
Reliable solutions for the
pharmaceutical industry. Weiss is the
global leader in environmental test
chambers for the pharmaceutical and
biomedical markets.
Wilco-USA
21 Commerce Dr.
North Branford, Connecticut 06471
USA
Tel: +1-203-484-9100
Fax: +41.56.618.4344
www.wilco.com
Contact: Paul Bilotti
paul.bilotti@wilco.com
Sophisticated and highly reliable leak
detection and testing systems:
Differential pressure & vacuum decay,
LFC leak testing and Head Space
Analysis.
www.ISPE.org/2015-Annual-Meeting
14 ISPE/FDA/PQRI Quality Manufacturing Conference
Upcoming
Conferences
Pharma EXPO*
28 – 30 September 2015
Las Vegas Convention Center
Las Vegas, NV
*A partnership with PMMI
Process Validation
Conference
7 – 8 October 2015
DoubleTree Hotel
Silver Spring, MD
ISPE China Annual
Fall Conference
October 2015
Shanghai, China
ISPE Annual Meeting
8 – 11 November 2015
Philadelphia Marriott Downtown
Philadelphia, PA
Thank You To Our Planning
Committee and Track
Leaders
FDA Co-Chair: Christine Moore, PhD, Acting
Director, Office of Process and Facilities,
FDA/CDER/OPQ/OPF
Industry Co-Chair: Joe Famulare, VP, Global
Compliance and External Collaboration, Pharma
Technical Quality, Genentech (A Member of the
Roche Group)
PQRI Co-Chair: Louis Yu, PhD, Executive Vice
President, Perrigo
Committee Members
• Tom Cosgrove, JD, Director, Office of Manufacturing
Quality, FDA/CDER/OC/OMQ
• Rose Mary Dollard, Director, Regulatory
Compliance, Johnson & Johnson
• Rick Friedman, Deputy Director, Science and Regulatory Policy, Office of Manufacturing Quality,
FDA/CDER/OC/OMQ
• Dora Kourti, PhD, Senior Technical Director, GlaxoSmithKline
• George Millili, PhD, Senior Principal Technical Advisor,
Genentech (A Member of the Roche Group)
Track Leaders
Modernization in Manufacturing
• Francis Godwin, Division Director, Division of Drug
Quality 2 (DDQ2), FDA/CDER/OC/OMQ
• David Clark, VP, Global Technical Operations, MedImmune/AstraZeneca
• Dora Kourti, PhD, Senior Technical Director, GlaxoSmithKline
www.ISPE.org/GlobalCalendar
• Lance Minor, Vice President of Operations Strategy & Network Performance,
MedImmune/AstraZeneca
Regulatory Insights
• Mahesh Ramanadham, PharmD, Regulatory Operations Officer, FDA/CDER/OPQ/OPF/DIA/IABI
• Rose Mary Dollard, Director, Regulatory Compliance,
Johnson & Johnson
• Steve Mahoney, Senior Director, Global Quality &
Compliance, Genentech (A Member of the
Roche Group)
• Tim Watson, PhD, Research Fellow, CMC Advisory
Office, Pfizer Inc.
Quality Systems
• Rick Friedman, Deputy Director, Science and Regulatory Policy, Office of Manufacturing Quality, FDA/CDER/OC/OMQ
• Lorraine McClain, Senior Director, Quality Risk Management, Teva Pharmaceuticals
• Stephen Tyler, Director, Quality Assurance, AbbVie
16 ISPE/FDA/PQRI Quality Manufacturing Conference
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
Thank You to Our Sponsors
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ISPE/FDA/PQRI Quality Manufacturing Conference
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Exhibit Hall Giveaway
Sponsor
Facility of the Year Awards
28 - 30 September 2015
Marquee Sponsor
18 ISPE/FDA/PQRI Quality Manufacturing Conference
Las Vegas, Nevada, USA
Banquet Sponsor
Coffee & Dessert
Sponsor
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