ISPE-FDA CGMP Conference
2 – 4 June, 2014 Baltimore, Maryland, USA Industry Chair: Joe Famulare, Vice President, Global Compliance, Pharma Technical Operations, Genentech and Rapporteur, ICH Q10 FDA Chair: Thomas Cosgrove, J.D., Acting Director, Office of Manufacturing and Product Quality, FDA/CDER/OC/OMPQ Monday, 2 June, 2014
QUALITY SYSTEMS: LIFECYCLE FROM DEVELOPMENT TO DISCONTINUATION
8:00 – 8:15
Welcome and Opening Remarks
 Joe Famulare, Vice President, Global Compliance and External Collaboration, Pharma Technical Quality,
Genentech Inc. and Rapporteur, ICH Q10
 Thomas Cosgrove, J.D., Acting Director, Office of Manufacturing and Product Quality
FDA/CDER/OC/OMPQ
8:15 – 8:45
Plenary Session – w/ Audience Q&A
Implementing and Measuring a Culture of Quality
 Mary Oates, Ph.D., VP, Global Quality Operations, Pfizer
8:45 – 9:15
Plenary Session – w/ Audience Q&A
Bringing Manufacturing, Science and Quality to the Next Level  Janet Woodcock, M.D., Director, FDA/CDER
9:15 – 10:20
ALL CONFERENCE SESSION
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, Ph.D., Professor/Director, CPIER, Peking University
09:55 – 10:20
Industry Update on Metrics
 Diane Hagerty, Head of Global Quality Systems and Processes, Genentech
10:20 – 11:00
Networking Break
11:00 – 12:00
Metrics Implementation Panel Discussion
Moderator: Bill Paulson, Editor-in-Chief, International Pharmaceutical Quality,
- Russ Wesdyk, OSP Scientific Coordinator, FDA/CDER/OSP
- Faiad Rahaman, Lead Operations Analyst, FDA/CDER/OSP
- Diane Hagerty, Head of Global Quality Systems and Processes, Genentech
- Fran Zipp, President, Lachman Consulting
- Laura Cannon, Senior Director, Quality, Teva
- Qiang Zheng, Ph.D., Professor/Director, CPIER Peking University
12:00 – 13:00
Lunch
13:00 – 14:15
BREAKOUT SESSIONS
TRACK 1:Challenges of Development: Anticipating
your Process
Industry Moderator: George Millili, Ph.D., Senior
Principal Technical Advisor , Genentech
TRACK 2: Maintaining a State of Control
FDA Moderator: David Doleski, Director, Office of
Manufacturing and Product Quality,
FDA/CDER/OC/DGMPA
FDA Moderator: Rick Friedman, Associate Director,
Office of Manufacturing and Product Quality
FDA/CDER/OMPQ
Tech Transfer
13:00– 13:25
Proactive Scale Up and Tech Transfer Practices,
“Anticipate Your Process”
 George Millili, Ph.D., Senior Principal
Technical Advisor , Genentech
13:25 – 13:50
Role of PAT in Quality/Technology Transfer
 Dora Kourti, Ph.D., Senior Technical Director
GSK
13:50 – 14:15
Audience Q&A
Industry Moderator: Chuck Hoiberg, Executive
Director, Pfizer
Combo Products: How GMP’s Work Together from
Device and Drug Product
13:00– 13:25
CDER Perspective
 Steve Hertz, Consumer Safety Officer,
FDA/CDER
13:25 – 13:50
CDRH Perspective
 M. Isabel Tejero del Rio, M.D., Ph.D., Acting
Lead, Quality System Working Group, Division
of Manufacturing & Quality, FDA/CDRH/OC
13:50 – 14:15
Audience Q&A
14:15 – 15:00
Networking Break
5/30/2014 10:06:30 AM 15:00 – 17:30
BREAKOUT SESSIONS
TRACK 1: Challenges of Development – Anticipating TRACK 2: Maintaining a State of Control
your Process
Knowledge Management
15:00 – 15:25
A Practical Approach for Managing Knowledge:
Overview of the Publication in Pharm. Engineering
 Marty Lipa, Executive Director, MMD
Knowledge Management, Merck
 Rob Guenard, Director, Merck
ISPE’s Stratified Sampling White Paper: Assessing
Blend and Content Uniformity
15:00 – 16:30
Sampling Plans  Jim Bergum, Ph.D., President, BergumSTATS Application of ASTMs for Assessing Uniformity
 Jim Bergum, Ph.D., President, BergumSTATS 15:25 – 15:50
How Process Monitoring Feeds into Knowledge
Management
 Claudia Lin, Berkeley Site Head, QA-Dev,
Bayer
Revisions to Stratified Sampling Approach  Jim Prescott, Senior Consultant, Jenike and
Johanson
15:50 – 16:15
Audience Q&A
Drug Specific Considerations When Assessing
Content Uniformity
 Ravi Tejwani, Ph.D., Senior Principal Research
Scientist, BMS
Breakthrough Therapy
16:30 – 16:50
FDA Current Experiences
 Sarah Pope Miksinski, Ph.D., Director
(Acting), ONDQA/DNDQA 2, FDA
16:50 – 17:10
Summary of ISPE Draft Break Through white paper
o Eric Thostesen, Senior Director Strategic Business Support, Johnson
& Johnson
17:10 – 17:30
Audience Q&A
17:30 – 19:00
Networking Reception in Exhibit Hall
5/30/2014 10:06:30 AM Process Validation
16:30 – 16:50
ISPE Statistics in Support of the Lifecycle Approach
to Process Validation Forum – Overview, Issues and
Opportunities
 Joanne Barrick, R.Ph., 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
Audience Q&A
19:00 – 20:30
Process Validation Night Session
Moderator: Jenn Walsh, Associate Director Manufacturing Technology, Bristol Myers Squibb
- Alex Viehmann, Operations Research Analyst , CDER/OPS/SRS, FDA
- Karthik Iyer, Senior Policy Analyst, CDER/OC/OMPQ, FDA
- Dafni Bika, Ph.D.,VP, Global Manufacturing and Supply, Bristol-Myers Squibb, USA
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
20.00 – 20.30
Panel Discussion with Question & Answer
Dafni Bika, Ph.D., Karthik Iyer, Alex Viehmann, Rick Friedman
Tuesday, 3 June, 2014
DATA INTEGRITY
7:00 – 08:00
BREAKFAST SESSION: Assessing Blend and Content Uniformity Discussion
Moderator: Tom Garcia, Research Fellow, Pfizer
Breakfast Description: Update on ISPE Stratified Sampling White Paper, including USP impact. Need and desires
of what team is working on, with FDA participation. The session will end with the opportunity for the audience to
ask questions to help foster transparency.
Jon Clark, Vice President, Chemical Medicines, USP
Panel Members:  Jim Bergum, Ph.D., President, BergumSTATS
 Jim Prescott, Senior Consultant, Jenike and Johanson
 Jon Clark, Vice President, Chemical Medicines, USP
 Ravi Tejwani, Ph.D., Senior Principal Research Scientist, BMS
 Will Brown, Senior Scientific Liaison, USP
 Rick Friedman, Associate Director, Office of Manufacturing and Product Quality FDA/CDER/OMPQ,
invited
 Alex Viehmann, Operations Research Analyst , FDA/CDER/OPS/SRS
5/30/2014 10:06:30 AM 8:15 – 8:30
Welcome Day 2 Moderators
 Thomas Cosgrove, J.D., Acting Director, Office of Manufacturing and Product Quality
FDA/CDER/OC/OMPQ
 Elaine Eborall, Ph.D., Senior Director, Genentech
8:30 – 9:00
Plenary Session – w/ Audience Q&A
Data Integrity: An EU Perspective
 Gerald Heddell, Director, Inspection Enforcement and Standards Division, MHRA
9:00 – 9:30
Plenary Session – w/ Audience Q&A
Approaches in Assuring Reliable Supply from India
 David Smith, Executive Vice-President, Global Operations & IS, AstraZeneca
9:30 – 10:00
FDA Perspective: Current Inspectional & Compliance Issues in Data Integrity
 Carmelo Rosa, Ph.D., Director, FDA/DIDQ
10:00 – 10:30
Auditing Manufacturing Operations for Data Integrity
 Elaine Eborall, Senior Director, Genentech
10:30 – 11:15
Networking Break
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
13:30 – 14:00
Labs - Data Integrity
 Mark Newton, Consultant-QA, Eli Lilly & Co. 14:00 – 14:30
The importance of managing data integrity throughout the computer system lifecycle, including the Concept,
Project, Operation, and Retirement Phases
 Sion Wyn, Director, Conformity Ltd.
5/30/2014 10:06:30 AM 14:30 – 15:00
Considerations for a Corporate Data Integrity Program
 John Avellanet, Managing Director, Cerulean Associates, LLC
15:00 – 15:30
Networking Break
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:– w/ Audience Q&A Global Supply & Emerging Markets
 Ilisa Bernstein, Pharm D, J.D., Deputy Director, Office Compliance, FDA/CDER
16:20 – 17:00
Audience Q&A
17:00 – 18:00
Open Discussion ISPE Metrics Follow-up
Moderator: Diane Hagerty, Genentech
18:30 – 19:15
FOYA RECEPTION
19:30 – 22:30
FOYA BANQUET
Wednesday, 4 June, 2014
DRUG SHORTAGE
-----CMO Executive Workshop Begins----7:00 – 8:00
BREAKFAST SESSION: Breakfast with the Inspectors
Moderator: Rick Friedman, Associate Director, Office of Manufacturing and Product Quality FDA/CDER/OMPQ
Breakfast Description:
Inspector Panel Members:  Rachel Harrington, Supervisory Consumer Safety Officer, FDA/ORA/OGROP
 Ernie Bizjak, Compliance Officer, FDA/ORA/OGROP
5/30/2014 10:06:30 AM 8:30 – 8:40
Opening Remarks
 Joe Famulare, Vice President, Global Compliance and External Collaboration, Pharma Technical Quality,
Genentech Inc. and Rapporteur, ICH Q10
 Thomas Cosgrove, J.D., Acting Director, Office of Manufacturing and Product Quality
FDA/CDER/OC/OMPQ
 Tim Tyson, Chairman and CEO, Aptuit, Inc.
8:40 – 9:40
Plenary Session – w/ Audience Q&A
Moderators: Francois Sallans, VP & Chief Quality Officer, Pharmaceutical, Johnson & Johnson
Joe Famulare, Vice President, Global Compliance and External Collaboration, Pharma Technical
Quality, Genentech Inc. and Rapporteur, ICH Q10
The Impact of CMO Governance on Drug Shortages
 Doug Throckmorton, M.D., Deputy Director, Regulatory Programs, FDA/CDER
Drug Shortages – UK Response
 Gerald Heddell, Director, Inspection Enforcement and Standards Division, MHRA
9:40 – 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
- Sam Venugopal, Director, PricewaterhouseCoopers
 EMA Overview on Drug Shortage
- Sabine Haubenreisser Ph.D. EMA-FDA Liaison, FDA/OC/OGROP/OIP
 Drug Shortages - the Inter-Association Prevention Project
- John Berridge, PhD, CChem, FRSC, Pharma Quality & Reg., Strategic Advisor, ISPE
 CMC Working Group Update
- Karen Hirshfield, R.Ph., Senior Compliance Specialist, Genentech
10:40 – 11:00
Networking Break
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. and Rapporteur, ICH Q10
 John Berridge, PhD, CChem, FRSC, Pharma Quality & Reg., Strategic Advisor, ISPE
 Sam Venugopal, Director, PricewaterhouseCoopers
 Larry Kranking, Executive Director, Commissioning Agents, Inc.
 Karen Hirshfield, R.Ph., Senior Compliance Specialist, Genentech
 Thomas Cosgrove, J.D., Acting Director, Office of Manufacturing and Product Quality
FDA/CDER/OC/OMPQ
 Francois Sallans, VP & Chief Quality Officer, Pharmaceutical, Johnson & Johnson
 Doug Throckmorton, M.D., Deputy Director, Regulatory Programs, FDA/CDER
5/30/2014 10:06:30 AM 
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Gerald Heddell, Director, Inspection Enforcement and Standards Division, MHRA, invited
Sabine Haubenreisser Ph.D. EMA-FDA Liaison, FDA/OC/OGROP/OIP Fran Zipp, President, Lachman Consulting
12:00 – 13:00
Lunch
-----CMO Executive Workshop Continues-----
5/30/2014 10:06:30 AM