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, EHS and Global Quality Operations, 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, Acting Director, Office of Compliance, 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 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, Acting Director, Office of Compliance, FDA/CDER/OC, USA
                        • Leader: Joseph Famulare, VP, Global Compliance and External Collaboration, Pharma Technical Quality, 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
                        • Leader: Joseph Famulare, VP, Global Compliance and External Collaboration, Pharma Technical Quality, Genentech/Roche, USA
                        • John Berridge, PhD, CChem, FRSC, Pharma Quality & Reg., United Kingdom
                        • Thomas Cosgrove, JD, Acting Director, Office of Compliance, FDA/CDER/OC, USA
                        • Sabine Haubenreisser, PhD, EMA-FDA Liason, FDA/OC/OGROP/OIP, USA
                        • Gerald Heddell, Dir, Inspection Enforcement and Standards Division, MHRA, United Kingdom
                        • Karen Hirshfield, RPh, Senior Compliance Specialist, Genentech-Member of Roche Group, USA
                        • Larry Kranking, Vice President, International Consulting, Commissioning Agents, Inc., USA, Invited
                        • François Sallans, PharmD, VP Quality & Compliance, Chief Quality Officer, Johnson & Johnson, USA
                        • Douglas Throckmorton, MD, Deputy Center Director for Regulatory Programs, FDA/CDER, USA
                        • Sumanth Venugopal, Partner, PricewaterhouseCoopers LLP, USA
                        • Frances Zipp, President & CEO, Lachman Consultant Services, USA
                        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