2014 ISPE CGMP Conference

Schedule-at-a-Glance

Monday, 2 June

00:00 - 00:00  QUALITY SYSTEMS: Lifecycle From Development to Discontinuation
08:00 - 08:15  Welcome and Opening Remarks
08:15 - 08:45  Plenary Session - w/Audience Q&A
  • Mary Oates, PhD, Vice President, PGS Network Excellence, Biotech and Consumer Manuf Ops, Pfizer, Inc., USA
    Implementing and Measuring a Culture of Quality
08:45 - 09:15  Plenary Session - w/Audience Q&A
09:15 - 09:30  Overview
  • Russell Wesdyk, OPS Scientific Coordinator, FDA/CDER/OPS/IO, USA
    Quality Metrics Update for ISPEStakeholder Feedback, Goals, and Gaps
09:15 - 10:20  ALL CONFERENCE SESSION
09:30 - 09:55  Metrics Initiative in China
09:55 - 10:20  Industry Update on Metrics
  • Diane Hagerty, Vice President, Genentech Inc, USA
    Industry Update on Quality Metrics
10:20 - 11:00  Networking Break
11:00 - 12:00  Metrics Implementation Panel Discussion
12:00 - 13:00  Lunch
13:00 - 13:25   Proactive Scale Up and Tech Transfer Practices, "Anticipate Your Process"
13:00 - 13:25  CDER Perspective
13:00 - 14:15  TRACK 1: CHALLENGES OF DEVELOPMENT: ANTICIPATING YOUR PROCESS:
Tech Transfer
    13:00 - 14:15  TRACK 2: MAINTAINING A STATE OF CONTROL:
    Combo Products: How GMP's Work Together from Device and Drug Product
      13:00 - 17:30  BREAKOUT SESSION - TRACK 1: Challenges of Development: Anticipating your Process
      13:00 - 17:30  BREAKOUT SESSION - TRACK 2: Maintaining a State of Control
      13:25 - 13:50  CDRH Perspective
      13:25 - 13:50  Role of PAT in Quality/Technology Transfer
      13:50 - 14:15  Audience Q&A
        13:50 - 14:15  Audience Q&A
          14:15 - 15:00  Networking Break
          15:00 - 15:25  Overview of Merck PT Publication
          15:00 - 16:15  TRACK 1: CHALLENGES OF DEVELOPMENT: ANTICIPATING YOUR PROCESS:
          Knowledge Management
            15:00 - 16:30  TRACK 2: MAINTAINING A STATE OF CONTROL:
            ISPE Stratified Sampling White Paper: Assessing Blend and Content Uniformity
            • James Bergum, PhD, President, BergumSTATS, LLC, USA
              Sampling Plans
              Application of ASTMs for Assessing Uniformity
              ASTM E2810/E2790 Acceptance Limit Tables with 90% Confidence / 95% Coverage to Pass USP <905>
              ASTM E2810/E2790 Acceptance Limit Tables with 50% Confidence/ 95% Coverage to Pass USP <905>
              ACCEPTANCE LIMITS FOR CONTENT UNIFORMITY SAMPLING PLAN 2
              ASTM E2810/E2709 Acceptance Limit Tables with 90% Confidence/ 95% Coverage to Pass USP <905> Sampling Plan 2 - 20x3
              ASTM E2810/E2709 Acceptance Limit Tables with 90% Confidence/ 95% Coverage to Pass USP <905> Sampling Plan 2 - 40x3
            • James Prescott, Senior Consultant/Director, Jenike & Johanson Inc, USA
              Revisions to Stratified Sampling Approach
            • Ravindra Tejwani, Ph.D., Senior Principal Research Scientist, Bristol-Myers Squibb, USA
              Drug Specific Considerations When Assessing Content Uniformity
            15:25 - 15:50  How Process Monitoring Feeds into Knowledge Management
              15:50 - 16:15  Audience Q&A
                16:30 - 16:50  FDA Current Experiences
                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, USA
                  ISPE Statistics in Support of the Lifecycle Approach to Process Validation Forum – Overview, Issues and Opportunities
                16:30 - 17:30  TRACK 2: MAINTAINING A STATE OF CONTROL:
                Process Validation
                  16:30 - 17:30  TRACK 1: CHALLENGES OF DEVELOPMENT: ANTICIPATING YOUR PROCESS:
                  BREAKTHROUGH THERAPY
                    16:50 - 17:10  Lessons Learned and Case Studies
                    16:50 - 17:10  Statistics, Testing and Process Controls
                    • Alex Viehmann, Operations Research Analyst, FDA/CDER/OPQ/OS, USA
                      Application of Pharmaceutical Quality Statistics
                    17:10 - 17:30  Audience Q&A
                      17:10 - 17:30  Audience Q&A
                        17:30 - 19:00  Networking Reception in Exhibit Hall
                        19:00 - 20:30  Night Session:
                        • Process Validation Discussion

                        Tuesday, 3 June

                        00:00 - 00:00  DATA INTEGRITY
                        07:00 - 08:00   BREAKFAST SESSION: Assessing Blend and Content Uniformity
                        Update on ISPE Stratified Sampling White Paper
                        08:00 - 08:30  Welcome Day 2
                        • Leader: Thomas Cosgrove, JD, Director, Office of Manufacturing Quality, FDA/CDER/OC, USA
                        • Leader: Elaine Eborall, Head of Global Compliance Audit, Genentech Inc, USA
                        08:30 - 09:00  Plenary Session - w/Audience Q&A
                        09:00 - 09:30  Plenary Session - w/Audience Q&A
                        09:30 - 10:00  FDA Perspective: Current Inspectional & Compliance Issues in Data Integrity
                        • Carmelo Rosa, Ph.D., Director DIvision of International Drug Quality, DIDQ, FDA, USA
                          Current Inspectional and Compliance Issues in Data IntegrityData Integrity Breaches:Perception, Misunderstanding, or Reality ?
                        10:00 - 10:30  Auditing Manufacturing Operations for Data Integrity
                        • Elaine Eborall, Head of Global Compliance Audit, Genentech Inc, USA
                          Detecting GMP Data Integrity Issues
                        10:30 - 11:15  Networking Break
                        11:15 - 12:15  Rocking the Foundation: Data Integrity Questions
                        12:15 - 13:30  Lunch
                        13:30 - 14:00  Labs: Data Integrity
                        14:00 - 14:30  The Importance of Managing Data Integrity throughout the Computer System Lifecycle, Including the Concept, Project, Operation and Retirement Phases
                        14:30 - 15:00  Considerations for a Corporate Data Integrity Program
                        15:00 - 15:30  Networking Break
                        15:30 - 16:00  Importance of Data Integrity in Corporate Lifecycle and Ethics
                        16:00 - 16:20  Plenary Session: w/Audience Q&A
                        • Ilisa Bernstein, Pharm.D., J.D., Deputy Director, Office of Compliance, FDA/CDER, USA
                          Our Global Drug Supply-containing the challenges
                        16:20 - 17:00  Audience Q&A
                          17:00 - 18:00  ISPE Metrics Follow-up
                          • Leader: Diane Hagerty, Vice President, Genentech Inc, USA
                            Quality Metrics QA Session
                          18:30 - 19:15  FOYA RECEPTION
                          19:30 - 22:30  FOYA BANQUET

                          Wednesday, 4 June

                          00:00 - 00:00  DRUG SHORTAGE
                          07:00 - 08:00  BREAKFAST SESSION: Breakfast with the Inspectors
                          08:30 - 08:40  Opening Remarks
                          • Leader: Thomas Cosgrove, JD, Director, Office of Manufacturing Quality, FDA/CDER/OC, USA
                          • Leader: Joseph Famulare, Vice President, Global Compliance, Genentech/Roche, USA
                          08:40 - 09:40  Plenary Session - w/Audience Q&A
                          09:40 - 10:40  ISPE Drug Shortage Updates
                          10:40 - 11:00  Networking Break
                          11:00 - 12:00  Industry-Regulatory Round Table: Implications of the Findings of the Drug Shortages Task Force
                          12:00 - 13:00  Lunch

                           

                          KEYNOTE SPEAKERS CONFIRMED!

                          JANET WOODCOCK, MD, Director, FDA/CDER, USA

                          Bringing Manufacturing, Science and Quality to the Next Level

                          MARY OATES, PhD, Vice President, Global Quality Operations, Pfizer Inc., USA

                          Implementing and Measuring a Culture of Quality

                          DAVID SMITH, Executive Vice President, Global Operations & IS, AstraZeneca, UK

                          Approaches in Assuring Reliable Supply from India

                          ILISA BERNSTEIN, PHARM D, JD,, Deputy Director, Office Compliance, FDA/CDER, USA

                          Global Supply and Emerging Markets

                          GERALD HEDDELL, Director, Inspection Enforcement & Standards Division, MHRA, UK

                          European Perspective on Data Integrity

                          MEET OUR PROGRAM COMMITTEE!

                          Mike Arnold, Senior Director, Strategic Partnerships, Pfizer Global Clinical Supplies, USA

                          Thomas Cosgrove, JD, Director, Office of Manufacturing and Product Quality, FDA

                          David Doleski, Director, Division of DGMPA, FDA

                          Joe Famulare, VP, Global Compliance and External Collaboration , Pharma Technical Quality, Genentech Inc., USA

                          Rick Friedman, Associate Director, Office of Manufacturing & Product Quality, FDA

                          Brian Hasselbalch, Consumer Safety Officer, CDER, FDA

                          Charles Hoiberg, Executive Director, Pfizer Inc., USA

                          George Millili, Senior Principal Technical Advisor, Genentech Inc., USA

                          Mike Smedley, Deputy Director, Office of Compliance, FDA