EVENT
3rd Annual
ISPE-FDA
CGMP
Conference
2 – 4 June 2014
Baltimore, Maryland USA
Hilton Baltimore
EVENT GUIDE
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Are Your Pharmaceutical
Quality Systems
Robust–Reliable–Secure?
Keynote Speakers:
Implementing and Measuring a
Culture of Quality
Mary Oates, PhD
VP, Global Quality Operations, Pfizer Inc.
Monday 2 June
08.15 - 08.45
Data Integrity: An European
Perspective MHRA
Gerald Heddell, Director, Inspection
Enforcement and Standards Division, MHRA
Tuesday 3 June
08.30 - 09.00
Bringing Manufacturing, Science
and Quality to the Next Level
Janet Woodcock, MD
Director, FDA/CDER
Monday 2 June
08.45 - 09.15
Approaches in Assuring Reliable
Supply from India
David Smith
Executive Vice President, Global
Operations and IS, AstraZeneca
Tuesday 3 June
09.00 - 09.30
Global Supply &
Emerging Markets
Ilisa Bernstein, PharmD, JD
Deputy Director, FDA/CDER/OC
Tuesday 3 June
16.00 - 16.20
1.5 ISPE CEUs will be given to all conference attendees.
2
ISPE-FDA CGMP CONFERENCE - 3rd Annual 2014
BREAKFAST SESSIONS:
Assessing Blend and Content Uniformity
Discussion
Tuesday, 3 June 2014
07.00 – 08.00
Location: Holiday Ballroom 1-3
Breakfast with the Inspectors
Wednesday, 4 June 2014
07.00 – 08.00
Location: Holiday Ballroom 1-3
JOINT CGMP-CMO SESSION:
Drug Shortages
Wednesday, 4 June 2014
8.30 – 12.00
Location: Holiday Ballroom 1 -3
NIGHT SESSIONS:
Process Validation
Monday, 2 June 2014
19.00 – 20.30
Location: Peale A-C (1st floor)
ISPE Metrics Follow-Up
Tuesday, 3 June 2014
17.00 – 18.00
Location: Peale A-C (1st floor)
EXTRA EVENT:
Sunday Reception Hosted by Chesapeake
Bay Chapter
Tickets for event available at ISPE Registration
Sunday, 1 June 2014, 17.00 – 19.00. Happy
hour with open bar and heavy hors d’oeuvres.
Location: Pratt Street Ale House, 206 W. Pratt
Street, Baltimore, MD 21201.
ISPE Members: $30 per person
Non-Members: $50 per person
WIRELESS DIRECTIONS
Select: HiltonMTG for preferred
network
Code: ISPE2014
* For detailed information regarding special
session content, visit the ISPE Registration
3rd Annual
ISPE-FDA
CGMP
Conference
Monday, 2 June 2014
Quality Systems: Lifecycle from Development to Discontinuation
08.00 – 08.15
Welcome and Opening Remarks Holiday Ballroom 1-3
Joe Famulare, Vice President, Global Compliance
and External Collaboration, Pharma Technical Quality,
Genentech, Inc. and Rapporteur, ICH Q10
08.15 – 08.45
Thomas Cosgrove, J.D., Acting Director, Office of
Manufacturing and Product Quality FDA/CDER/OC/
OMPQ
PLENARY SESSION w/Audience Q&A
Implementing and Measuring a Culture of Quality
Mary Oates, PhD, VP, Global Quality Operations, Pfizer Inc.
08.45 – 09.15
PLENARY SESSION w/Audience Q&A
Bringing Manufacturing, Science and Quality to the Next Level
Janet Woodcock, MD, Director, FDA/CDER
09.15 – 10.20
ALL CONFERENCE SESSION Holiday Ballroom 1-3
Metrics Implementation Overview
FDA Moderator: Russ Wesdyk, OPS Scientific Coordinator, FDA/CDER/OPS
Industry Moderator: Fran Zipp, President, Lachman Consulting
09.15 – 09.30
Overview
Russ Wesdyk, OPS Scientific Coordinator, FDA/CDER/OPS
09.30 – 09.55
Metrics Initiative in China
Qiang Zheng, PhD, Professor/Director, CPIER, Peking University,
09.55 – 10.20
Industry Update on Metrics
Diane Hagerty, Head of Global Quality Systems and Processes, Genentech, Inc.
10.20 – 11.00
Networking Break (Foyer)
11.00 – 12.00
Metrics Implementation Panel Discussion Holiday Ballroom 1-3
Moderator: Bill Paulson, Editor-in-Chief, International Pharmaceutical Quality
Laura Cannon, Sr. Director, Quality, Teva
Diane Hagerty, Head of Global Quality Systems and Processes, Genentech, Inc.
Faiad Rahaman, Lead Operations Analyst, FDA/CDER/OSP
Jason Urban, Senior Staff Fellow in Drug Quality and Surveillance, FDA/CDER/OSP
Russ Wesdyk, OPS Scientific Coordinator, FDA/CDER/OPS
Qiang Zheng, PhD, Professor/Director, CPIER, Peking University
Fran Zipp, President, Lachman Consulting
12.00 – 13.00
Lunch (in the Exhibit Hall)
* Standing Microphones
available for Audience
questions
ISPE-FDA CGMP CONFERENCE - 3rd Annual 2014
* If you do not want to ask your
question publically please utilize an
ISPE question card and return to ISPE staff
3
13.00 – 14.15
BREAKOUT SESSIONS
TRACK 1: Challenges of Development—Anticipating
Your Process Peale A-C (First Floor)
Industry Moderator: George Millili, PhD, Senior Principal
Technical Advisor, Genentech, Inc.
FDA Moderator: David Doleski, Director, Office of Manufacturing
and Product Quality, FDA/CDER/OC/DGMPA
TRACK 2: Maintaining a State of Control
Holiday Ballroom 1-3
Industry Moderator: Chuck Hoiberg, Executive Director, Pfizer Inc.
FDA Moderator: Rick Friedman, Associate Director, Office of
Manufacturing & Product Quality, FDA/CDER/OMPQ
COMBO PRODUCTS: HOW
GMPs WORK TOGETHER FROM
DEVICE AND DRUG PRODUCT
TECH TRANSFER
13.00 – 13.25 Proactive Scale-Up and
Tech Transfer Practices, “Anticipate Your
Process”
George Millili, PhD, Senior Principal Technical
Advisor, Genentech, Inc.
13.00 – 13.25 CDER Perspective
Steve Hertz, Consumer Safety Officer, FDA/CDER
13.25 – 13.50 Role of PAT in Quality/Technology Transfer
13.25 – 13.50 CDRH Perspective
Dora Kourti, PhD, Senior Technical Director, GSK
M. Isabela Tejero del Rio, M.D., Ph.D., Acting
Lead, Quality System Working Group, Division of
Manufacturing & Quality, FDA/CDRH/OC
13.50 – 14.15
14.15
– 15.00
15.00 – 17.30
Audience Q&A
13.50 – 14.15
Audience Q&A
Networking Break In Exhibit Hall
BREAKOUT SESSIONS
TRACK 1: C
hallenges of Development—Anticipating
TRACK 2: Maintaining a State of Control
Your Process
KNOWLEDGE MANAGEMENT
ISPE’S STRATIFIED SAMPLING
WHITE PAPER: ASSESSING
Holiday Ballroom 1-3
BLEND AND CONTENT
UNIFORMITY Peale A-C (First Floor)
15.00 – 15.25 A Practical Approach for Managing Knowledge: 15.00 – 16.30
Overview of the Publication in Pharm. Eng
Marty Lipa, Executive Director, MMD Knowledge
Management, Merck
Rob Guenard, Director, Merck
15.25 – 15.50 How Process Monitoring Feeds into Knowledge
Management
Claudia Lin, Berkeley Site Head,
QA-Dev, Bayer
15.50 – 16.15
Audience Q&A
BREAKTHROUGH THERAPY
PROCESS VALIDATION
Peale A-C (First Floor)
Holiday Ballroom 1-3
16.30 – 16.50 FDA Current Experiences
Sarah Pope Miksinski, PhD, Director (Acting),
FDA/ONDQA/DNDQA 2
16.50
– 17.10
Summary of ISPE Draft Break Through White
Paper
Eric Thostesen, Sr Director Strategic Bus.
Support, Johnson & Johnson
17.10
– 17.30
Audience Q&A
17.30 – 19.00
4
Sampling Plans
Jim Bergum, PhD, President, BergumSTATS
Application of ASTMs for Assessing Uniformity
Jim Bergum, PhD, President, BergumSTATS
Revisions to Stratified Sampling Approach
Jim Prescott, Senior Consultant, Jenike and
Johanson
Drug Specific Considerations When Assessing
Content Uniformity
Ravi Tejwani, PhD Senior Principal Research
Scientist, BMS
16.30 – 16.50 ISPE Statistics in Support of the Lifecycle
Approach to Process Validation Forum – Overview,
Issues and Opportunities
Joanne Barrick, RPh, Advisor, Global Validation, Eli
Lilly & Co.
16.50 – 17.10 Statistics, Testing and Process Controls
Alex Viehmann, Operations Research Analyst ,
FDA/CDER/OPS/SRS
17.10 – 17.30
Networking Reception (in the Exhibit Hall)
ISPE-FDA CGMP CONFERENCE - 3rd Annual 2014
Audience Q&A
19.00 – 20.30
NIGHT SESSION Peale A-C (First Floor)
Process Validation
Moderator: Jenn Walsh, Associate Director Manufacturing Technology, Bristol Myers Squibb
19.00 – 19.05 Welcome and Introduction
Jenn Walsh, BMS
19.05 – 19.30 Industry Case Study: Implementation Status of the Lifecycle Validation Paradigm
Dafni Bika, Ph.D., BMS
19.30 – 20.00 FDA Perspective on the New Paradigm in Validation: Observations and Findings from Recent Inspections
Karthik Iyer and Alex Viehmann
Panel Discussion with Question & Answer
–
20.30
20.00
Dafni Bika, Ph.D., Karthik Iyer, Alex Viehmann, Rick Friedman
Tuesday, 3 June 2014
DATA INTEGRITY
07.00 – 08.00
BREAKFAST SESSION Holiday Ballroom 1-3
Assessing Blend and Content Uniformity: Update on ISPE Stratified Sampling White Paper
Moderator: Tom Garcia, Research Fellow, Pfizer Inc.
Jon Clark, VP, Chemical Medicines, USP
Jim Bergum, PhD, President, BergumSTATS
Will Brown, Senior Scientific Liaison, USP
Rick Friedman, Associate Director, Office of Manufacturing & Product Quality FDA/CDER/OMPQ
Jim Prescott, Senior Consultant, Jenike and Johanson
Ravi Tejwani, PhD, Senior Principal Research Scientist, BMS
Alex Viehmann, Operations Research Analyst, FDA/CDER/OPS/SRS
08.00 – 08.30
WELCOME Holiday Ballroom 1-3
FDA Moderator: Thomas Cosgrove, J.D., Acting Director, Office of Manufacturing and Product Quality FDA/CDER/OC/OMPQ
Industry Moderator: Elaine Eborall, Ph.D., Senior Director, Vertex
PLENARY SESSION w/Audience Q&A
08.30 – 09.00 European Perspective on Data Integrity
Gerald Heddell, Director, Inspection Enforcement and Standards Division, MHRA
09.00 – 09.30 Approaches to Assuring Reliable Supply from India
David Smith, Executive Vice President, Global Operations and IS, AstraZeneca
09.30 – 10.00 FDA Perspective: Current Inspectional & Compliance Issues in Data Integrity
Carmelo Rosa, Director, FDA/DIDQ
10.00 – 10.30 Auditing Manufacturing Operations for Data Integrity
Elaine Eborall, Ph.D., Director, Genentech, Inc.
10.30 – 11.15
Networking Break (in the Exhibit Hall)
11.15 – 12.15 Legal Aspects of Data Integrity
Doug Stearn, Director, Office of Enforcement and Import Operations, FDA/ORA/OGROP/OEIO
Jennifer Zachary, JD, Partner, Covington & Burling LLP
12.15 – 13.30
Lunch (in the Exhibit Hall)
13.30 – 14.00 Labs - Data Integrity Holiday Ballroom 1-3
Mark Newton, Consultant-QA, Eli Lilly & Co.
14.00 – 14.30 The Importance of Managing Data Integrity Throughout the Computer Systems Lifecycle, including Concept, Project,
Operation and Retirement Phases
Sion Wyn, Director, Conformity Ltd.
14.30 – 15.00 Considerations for a Corporate Data Integrity Program
John Avellanet, Managing Director, Cerulean Associates LLC
15.00 – 15.30
Networking Break (in the Exhibit Hall)
ISPE-FDA CGMP CONFERENCE - 3rd Annual 2014
5
15.30 – 16.00 Importance of Data Integrity in Corporate Lifecycle and Ethics
Paul Vogel, CEO, Lachman Consulting
Barry Rothman, Manager, Lachman Consulting
16.00 – 16.20
PLENARY SESSION
Global Supply & Emerging Markets
Ilisa Bernstein, PharmD, JD, Deputy Director, FDA/CDER/OC
16.20 – 17.00 Audience Q&A
17.00 – 18.00
NIGHT SESSION Peale A-C (First Floor)
Open Discussion ISPE Metrics Follow-Up
Moderator: Diane Hagerty, Genentech
18.30 – 19.10
FOYA Reception Foyer
19.15 – 22.30
FOYA Banquet Holiday Ballroom 1-3
Tickets available at the registration desk
Wednesday, 4 June 2014
DRUG SHORTAGE
07.00 – 08.00
JOINT CGMP-CMO SESSION Holiday Ballroom 1-3
Breakfast with the Inspectors
Moderator: Thomas Cosgrove, J.D., Acting Director, Office of Manufacturing and Product Quality FDA/CDER/OC/OMPQ
Inspector Panel Members:
Ernie Bizjak, Compliance Officer, OHHS/FDA/ORA/OGROP, Invited
Rachel Harrington, Supervisory Consumer Safety Officer, FDA/ORA/OGROP
08.30 – 08.40 Opening Remarks
Joe Famulare, Vice President, Global Compliance and External Collaboration, Pharma Technical Quality, Genentech, Inc.
Thomas Cosgrove, J.D., Acting Director, Office of Manufacturing and Product Quality FDA/CDER/OC/OMPQ
Tim Tyson, Chairman and CEO, Aptuit, Inc.
08.40 – 09.40
PLENARY SESSION w/Audience Q&A
Modertaors: Francois Sallans, VP & Chief Quality Officer, Johnson & Johnson Pharmaceuticals
& Joe Famulare, VP, Global Complience and External Collaboration, Pharma Technical Quality, Genentech Inc. Rapporteur, ICH Q10
The Impact of CMO Governance on Drug Shortages
Doug Throckmorton, MD, Deputy Director, Regulatory Programs, FDA/CDER
Drug Shortages – UK Response
Gerald Heddell, Director, Inspection Enforcement and Standards Division, MHRA
09.40 – 10.40
ISPE DRUG SHORTAGE UPDATES
Report of the ISPE Drug Shortages Task Force on Emerging Strategies for Preventing and Mitigating Shortages
Operations Working Group Update
EMA Overview on Drug Shortage
Sam Venugopal, Director, PricewaterhouseCoopers
Sabine Haubenreisser, PhD, EMA Liaison to FDA, FDA/OC/
OGROP/OIP
Drug Storages - the Inter-Association Prevention Project
John Berridge, PhD, CChem, FRSC, Strategic Advisor, ISPE CMC Working Group Update
Karen Hirshfield, RPh, Senior Compliance Specialist,
Genentech, Inc.
10.40 – 11.00
Networking Break Foyer
11.00 – 12.00
INDUSTRY-REGULATORY ROUNDTABLE
Implications of the Findings of the Drug Shortages Task Force
Moderator: Joe Famulare, Vice President, Global Compliance and External Collaboration,
Pharma Technical Quality, Genentech, Inc.
Panel Members:
John Berridge, PhD, CChem, FRSC, Strategic Advisor, ISPE
Sabine Haubenreisser, PhD, EMA Liaison to FDA, FDA/OC/
OGROP/OIP
Gerald Heddell, Director, Inspection Enforcement and
Standards Division, MHRA
Larry Kranking, Executive Director, Commissioning Agents, Inc.
Thomas Cosgrove, J.D., Acting Director, Office of
Manufacturing and Product Quality FDA/CDER/OC/OMPQ
12.00 – 13.00
Lunch Holiday Ballroom 4-5
CMO Executive Workshop Continues
6
ISPE-FDA CGMP CONFERENCE - 3rd Annual 2014
Francois Sallans, VP & Chief Quality Officer, Johnson &
Johnson Pharmaceuticals
Doug Throckmorton, MD, Deputy Director, Regulatory
Programs, FDA/CDER
Sam Venugopal, Director, PricewaterhouseCoopers
Fran Zipp, President, Lachman Consulting
Karen Hirshfield, RPh, Senior Compliance Specialist,
Genentech, Inc.
Hotel Floor Plan
ISPE-FDA CGMP CONFERENCE - 3rd Annual 2014
7
Exhibition Floor Plan
Exhibit Hall Hours
The Exhibit Hall is located in the Holiday Ballroom
Tuesday, 3 June
10.00 – 15.30 Exhibit Hall Hours
10.30 – 11.15 Networking Break
12.15 – 13.30 Lunch
15.00 – 15.30 Networking Break
Monday , 2 June
12.00 – 19.00 Exhibit Hall Hours
12.00 – 13.00 Lunch
14.15 – 15.00 Networking Break
17.30 – 19.00 Networking Reception
Monday and Tuesday Lunches and Networking Breaks are in the Hall
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25
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ISPE-FDA CGMP CONFERENCE - 3rd Annual 2014
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34
Exibitors
Astro Pak
Camfil
CRB
560 Stelton Road, Suite 3
Piscataway, New Jersey 08854 USA
Tel: +1-908-566-1246
Fax: +1-949 270-0849
www.astropak.com
Contact: Carolyn Morgan
cmorgan@astropak.com
1 North Corporate Drive
Riverdale , NJ 07457 USA
Tel: +1-973-616-7300
Fax:+1- 973-616-7771
www.camfil.com
Contact: Matthew Crouch
Matthew.Crouch@Camfil.com
220 West Germantown Pike, Suite 170
Plymouth Meeting, PA 19462 USA
Tel: +1-610-278-7644
Fax: +1-610-278-9194
www.crbusa.com
Contact: Shannah Schodle
shannah.schodle@crbusa.com
Table #19
Table #23
Astro Pak is a global leader of high purity
cleaning and passivation technology serving customers in the biotechnology and
pharmaceutical industries. Our services and
products leverage decades of experience
to deliver the most effective chemistries
and techniques.
Camfil is the world’s leading air filtration
supplier to the Life Science Industry. Our
clean air solutions protect people and processes: custom supply and exhaust housings, autos can (in-place) systems, unique
high temperature HEPA filters, wide range
of HVAC filters and contained process dust
collection.
Azzur Group, LLC
cGMP Validation LLC
Table #17
726 Fitzwatertown Rd.
Willow Grove, Pennsylvania 19090 USA
Tel: +1-610-322-8322
Fax: +1-610-363-0428
www.azzurgroup.com
Contact: Bianca Makris
info@azzurgroup.com
Azzur Group is a full-service life science
consulting firm with expertise in Computer
Systems Validation, IT/IM Infrastructure,
Auditing, C&Q, Certification and Calibration.
Table #26
2325 Charleston Regional Parkway
Charleston, SC 29492-8320 USA
Tel: +1-843-216-7424
Fax: +1-843-216-7707
www.belimed.com
Contact: Ken Blankenship
ken.blankenship@belimed.us
A trusted leader w/ decades of experience,
Belimed takes pride in cultivating partnerships w/ customers like you to offer custom
solutions no matter what you need to wash
or sterilize.
Bosch Packaging
Technology
Table #6
8700 Wyoming Avenue North
Minneapolis, MN 55445 USA
Tel: +1-763-424-4700
www.boschpackaging.com
Contact: Dave Cousins
dave.cousins@bosch.com
Bosch Packaging Technology is the world
leader in the design and manufacture for
processing and packaging systems for the
pharmaceutical market.
ISPE-FDA CGMP CONFERENCE - 3rd Annual 2014
CRB provides front-end consulting, engineering, architectural, construction management and related services to pharmaceutical and biotechnology companies. We
can take total responsibility for project-planning, budgeting, design, construction and
start-up; or we can help with any individual
step along the way.
Table #9
10314 Shawnee Mission Pkwy, Suite 250
Shawnee, KS 66203 USA
Tel: +1-913-384-2221
or +1-973-229-0074
Fax: +1-913-384-2252
www.cgmpvalidation.com
Contact: Ernie Tyler
ernie.tyler@cgmpvalidation.com
Full validation services for all industries
Cleanseal Door Systems/ ASI
Table #31
Belimed
Table #8
5848 N. 95th Court
Milwaukee, WI 53225 USA
Tel: +1-800-558-7068
Fax: +1-414-464-9863
www.cleansealdoors.com
Contact: Brian Fulton
cinfo@cleansealdoors.com
Cleanseal offers a complete line of high
performance doors for clean environments. With styles to meet cGMP - Class
1 requirements, Cleanseal doors include
your choice of panel & hardware, frame &
interlocking designs.
Commissioning Agents
Table #1
P.O. Box 34320
Indianapolis, IN 46234 USA
Tel: +1-317-271-6082
Fax: +1-317-271-6097
www.cagents.com
Contact: Bob Chew, PE
info@cagents.com
Gateway Analytical
Table #11
5316 William Flynn Highway
Gibsonia, PA 15044 USA
Tel: +1-724-443-1900
Fax: +1-866-658-1445
www.gatewayanalytical.com
Contact: Brittney Norris
norrisb@gatewayanalytical.com
Gateway Analytical is a contract analytical
lab and consulting company offering standard and novel analytical testing techniques
for pharma, materials science and forensics
industries.
Genesis Packaging
Technologies
Table #24
435 Creamery Way, Suite 200
Exton, PA 19341 USA
Tel: +1-800-552-9980
Fax: +1-610-458-4939
www.gen-techno.com
Contact: Lawrence Pepper
lpepper@gen-techno.com
Genesis Packaging Technologies is the
leader in parenteral vial sealing technology.
Continuing a sixty year history of manufacturing and innovating the Westcapper.
CAI: Global provider of engineering, automation, technical and consulting service
that support cGMP manufacturing operations and capital project delivery. We
provide integrated commissioning/validation services, including factory inspections,
construction QA oversight, commissioning
and IQ/OQ/PQ.
9
Exibitors
Gerflor
i-Solutions
595 Supreme Drive
Bensenville, IL 60106 USA
Tel: +1-877-437-3567
Fax: +1-855-415-3715
www.gerflorusa.com
Contact: Michael Carey
mcarey@gerflorusa.com
PO Box 1019
Cary, NC 27519 USA
Tel: +1-919-380-0000
Fax: +1-919-303-3575
www.i-solutionsco.com
Contact: Jim Scandura
pr@i-solutionsco.com
Table #29
The Gerflor Group creates, manufactures
and markets innovative, design-led and
eco-responsible solutions for cleanroom
flooring that meet ISO and GMP requirements.
GP Strategies
Table #35
70 Corporate Center/11000 Broken Land
Parkway
Columbia, MD 21044 USA
Tel: +1-443-367-9600
Fax: +1-443-392-2905
www.gpstrategies.com
Contact: Nick Morris
nmorris@gpstrategies.com
GP Strategies is a global performance
improvement company leveraging expert
training and consulting to impact and
improve your sales, leadership, processes,
infrastructure, workforce and organization.
Hamo USA
Table #3
For more than a decade i-Solutions has
delivered a variety of services, solutions,
and unique technologies tailored specifically
to the Life Sciences Industry. i-Solutionsproprietary tools utilizes
extensive, multi-platform
attributes to generate
innovative business
solutions for companies.
IPS-Integrate Project
Services
Table #27
721 Arbor Way, Suite 100
Blue Bell, PA 19422 USA
Tel: +1-610-828-4090
Fax: +1-610-828-3656
www.ipsdb.com
Contact: Aaron Weinstein
aweinstein@ipsdb.com
IPS is a global leader in developing innovative solutions for the engineering, construction, commissioning and qualification of
complex biopharma research and manufacturing facilities.
Table #14
500 Office Center Dr.
Ft. Washington, PA 19034 USA
Tel: +1-855-467-9274
Fax: +1-855-554-2124
www.Hamo.com
Contact: Marie Van Buren
marie.vanburen@hamo.com
HAMO is a leading innovator of high tech
washing equipment for pharma and manufacturing, offering parts washers and high
pressure cleaning systems designed to
replace CIP processes.
InfinityQS International
Table #30
12601 Fair Lakes Circle, Suite 250
Fairfax, VA 22033 USA
Tel: +1-703-961-0200 Fax: 703-961-1923
www.infinityqs.com
Contact: Jack Lan
ebradford@infinityqs.com
Lyophilization Technology,
Inc.
Table #13
30 Indian Drive
Ivyland, PA 18974 USA
Tel: +1-215-396-8373
Fax: +1-215-396-8375
www.lyotechnology.com
Contact: Edward Trappler
inquiry@lyo-t.com
Lyophilization Technology offers thermal
analysis, product design, formulation development, process refinement, Phase I/II
clinical supply manufacturing, & consulting
for pharmaceuticals, biologics, diagnostics,
biopharmaceuticals, & medical devices.
ProFicient is a proven quality software platform that gives a complete, real-time view
of manufacturing operations, allowing them
to control quality throughout the product
lifecycle.
10
ISPE-FDA CGMP CONFERENCE - 3rd Annual 2014
Metrology Labs., Inc. /
FlatLine Chambers, LLC
Table #4
24 Norman Road
Rockaway, New Jersey 07866 USA
Tel: +1-973-625-7930
Fax: +1-973-627-8466
www.Metlabs-Inc.com
Contact: Marc Maleck
MLI_Marc@msn.com
MLI / FlatLine Chambers provides 24/7 onsite service, support to full calibration management. We also build new and upgrade
old stability chambers to be eco-friendly
and efficient.
Micro-Clean, Inc.
Table #25
177 N. Commerce Way
Bethlehem, PA 18017 USA
Tel: +1-800-523-9852
Fax: +1-610-954-7803
microcln.com
Contact: Laurie Wagner
lauriewagner@microcln.com
Refined by 40 year of experience, MicroClean provides service with GMP documentation for certification, compressed
air, EM, calibration, validation and smoke
pattern studies.
NNE Pharmaplan
Table #12
Perimeter Park ONE, 3005 Carrington Mill
Blvd., Suite 380
Morrisville, North Carolina 27560 USA
Tel: +1-866-810-4073
Fax: +1-919-763-1801
www.nnepharmaplan.com
Contact: Carol Brandt, Director GMP Compliance Consulting
cbt@nnepharmaplan.com
NNE Pharmaplan is one of the world’s leading engineering and consulting companies
within the life science industry. Engineering
for a healthier world – our role in an industry
that improves people’s lives worldwide.
Exibitors
NSF Health Sciences
PharmEng Technology Inc.
129 South Street, 6th Floor
Boston, MA 02111 USA
Tel: +1-857-277-0060
Fax: +1-857-284-7207
www.nsf.org/info/healthsciences
Contact: Austin Caudle
uspharma@nsf.org
2501 Blue Ridge Rd., Suite 250
Raleigh, North Carolina 27607 USA
Tel: +1-919-474-8309
Fax: +1-416-385-3912
www.pharmeng.com
Contact: Ben Lee
info@pharmeng.com
Table #21
NSF Health Sciences offers training and
education, consulting, auditing, GMP and
GLP analytical testing, certification, R&D,
regulatory guidance and corporate compliance throughout the product lifecycle.
Table #15
PharmEng Technology is a fully integrated
consulting firm serving the Biotechnology
and Pharmaceutical industry. We are cGMP
compliant leaders in providing services in
commissioning & qualification, validation,
quality systems, regulatory affairs, auditing,
process development, technology transfer,
and training.
QUMAS
Table #22
66 York Street
Jersey City, NJ 07302 USA
Tel: +1-973-805-8600
Fax: +1-973-377-8687
www.qumas.com
Contact: David Moneuse
info@qumas.com
QUMAS, an Accelrys company (NASDAQ:
ACCL), is the leader in Compliance and
Quality Management Software Solutions for
Life Sciences with 270+ global customer
deployments.
Telstar North America
Table #5
O’Neal, Inc.
Table #2
3000 RDU Center Drive, Suite 200
Morrisville, NC 27560 USA
Tel: +1-919-840-9500
Fax: +1-919-840-9522
www.onealinc.com
Contact: Robert Garner
rgarner@onealinc.com
O’Neal is an integrated design and construction firm that specializes in complex
pharmaceutical and biotechnology projects.
Our experience includes pharmaceutical
plant design, engineering, and construction.
Process Stream
Table #18
103 Carnegie Center
Princeton, New Jersey 08540 USA
Tel: +1-609-955-3549
Fax: +1-609-520-8731
www.process-stream.com
Contact: Mickey Shah
mickey.shah@process-stream.com
Process Stream develops enterprise-level IT
and business solutions for a wide range of
industries, particularly those where manufacturing quality control is essential.
Performance Validation
Table #28
Two Park Fletcher Suite 100
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 providing validation, commissioning, and quality
services for pharmaceutical and medical
device companies since 1988.
ProPharma Group
Table #20
8717 W 110th Street, 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 provides comprehensive
compliance solutions to the global pharmaceutical, biotechnology, and medical device
industries.
1504 Grundy’s Lane
Bristol, PA 19007 USA
Tel: +1-215-826-0770
Fax: +1-215-826-0222
www.telstar-lifesciences.com
Contact: Paul Stewart
telstar.na@telstar.eu
Supply of integrated process equipment
solutions for Sterilization, Lyophilization,
Containment & Barrier systems, Cleanroom
& LAF systems and Clean Utilities (PW, WFI,
Pure Steam).
UL EduNeering
Table #10
202 Carnegie Center, Suite 301
Princeton, New Jersey 08540 USA
Tel: +1-609-627-5390
Fax: +1-609-627-5330
uleduneering.com
Contact: Ellen Leinfuss
ellen.leinfuss@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®.
WHK BioSystems, LLC
Table #16
11345 53rd Street North
Clearwater, FL 33760 USA
Tel: +1-727-209-8406
Fax: +1-727-209-8407
www.whkbiosystems.com
Contact: Jerry Stadt
jerry.stadt@whkbiosystems.com
WHK provides a complete line of quality
Inspection Panels and Tables for use in the
medical, biopharmaceutical and electronics
industries to inspect product for non-visible
defects.
ISPE-FDA CGMP CONFERENCE - 3rd Annual 2014
11
Exchanging Ideas
Advancing Technology
Expanding Networks
The
Leading Edge
of Pharmaceutical
Innovation
Investigational Products
Information Systems
Manufacturing Facilities and Design
Manufacturing Technology
Project Management
Quality Systems
Regulatory and Compliance
Technical Showcases
Young Professionals
www.ISPE.org/2014AnnualMeeting
JOINT VENTURE
Smart Solutions
for
Lifecycle
Innovation
At Pharma EXPO, meet solutions providers who understand the importance of controlling the integrity
of your product throughout its lifecycle. Discuss your challenges with experts who know how the
industry’s systems work. Take away smart approaches to production so you can meet your goals for
yield, performance, safety and security—from start to finish.
Register today at pharmaexpo.com
Thank you to our Committee:
Mike Arnold, Senior Director, Strategic Partnerships, Pfizer Global Clinical Supplies
David Doleski, Director, Division of DGMPA, FDA
Joe Famulare, VP, Global Compliance and External Collaboration , Pharma Technical Quality, Genentech Inc.
Rick Friedman, Associate Director, Office of Manufacturing & Product Quality, FDA
Brian Hasselbalch, Consumer Safety Officer, CDER, FDA
Charles Hoiberg, Executive Director, Pfizer Inc.
Steve Lynn, Director, Office of Manufacturing and Product Quality, FDA
George Millili, Senior Principal Technical Advisor, Genentech Inc.
Mike Smedley, Deputy Director, Office of Compliance, FDA
Notes:
14
ISPE-FDA CGMP CONFERENCE - 3rd Annual 2014
Want to
stay for
CMO?
Register now at
the ISPE desk in
the foyer.
Notes:
ISPE-FDA CGMP CONFERENCE - 3rd Annual 2014
15