Process Validation Conference, 12 -14 September 2017, Bethesda Marriot, Bethesda, MD

Education Program

Register early to save and learn from notable regulatory experts and industry professionals, who will address your concerns and provide implementation guidance

Detailed Program

Tuesday, 12 September

0830 - 0900  Welcome, Agenda for the Day, Introductions and Benchmarking
  • Leader: Joanne Barrick, RPh, Advisor, Global Validation Support, Eli Lilly and Company, USA
    Conference Welcome
  • Leader: Brad Berkowicz, Director, Drug Product Technical Services, Shire, USA
    Process Validation Benchmarking
0900 - 0945  Keynote: FDA Perspective on Process Validation for Biotech Products
0945 - 1025  A Risk-Based Approach for Process Validation Stage 1- 3 Implementation
1025 - 1055  Networking Break
1055 - 1135  Criticality Assessment in PV Stage 1
1135 - 0015  PPQ on a New Flexible Vial Aseptic Filling Line: Case Study
  • Lauren Smith, Director, Validation, Cook Pharmica, USA
    PPQ on a New Flexible Vial Aseptic Filling Line: Case Study
1215 - 1315  Lunch
1315 - 1330  Benchmarking
  • Leader: Maneesha Altekar, PhD, Principal QA Statistician, AstraZeneca, USA
    Benchmarking
1330 - 1430  Translating Stage 1 Data to NOR, PAR and the Control Strategy: Small Group Exercise
  • Tara Scherder, Partner, SynoloStats, LLC, USA
    Translating Stage 1 Data to NOR, PAR and the Control Strategy: Small Group Exercise
1430 - 1510  Estimation of the Number of Batches Required for Validation of Solution Container Material and Manufacturing Process Modifications
  • Daniel Boggs, PhD, Engineering Consultant, Fresenius Kabi, USA
    Estimation of the Number of Batches Required for Validation of Solution Container Material and Manufacturing Process Modifications
1510 - 1540  Networking Break
1540 - 1605  Sampling and Acceptance Criteria for Process Performance Qualification - ISPE Discussion Paper (Draft)
  • Mark Johnson, Senior Principal Statistician, Research, AbbVie, USA
    Sampling and Acceptance Criteria for Process Performance Qualification – ISPE Discussion Paper (Draft)
1605 - 1635  Development of Attribute Process Validation Sampling Plans
  • James Wright, PhD, Senior Principal Statistician, Shire Pharmaceuticals, USA
    Development of Attribute Process Validation Sampling Plans
1635 - 1715  Q&A and Benchmarking
  • Leader: Maneesha Altekar, PhD, Principal QA Statistician, AstraZeneca, USA
    Benchmarking

Wednesday, 13 September

0800 - 0830  Agenda for the Day| Bechmarking Session
  • Leader: Brad Berkowicz, Director, Drug Product Technical Services, Shire, USA
0830 - 0915  Keynote: Stage 3 Process Validation and the Role of Quality Risk Management
0915 - 0950  OPV Process and Decision Making for Large Molecule Drug Substance: Case Study
0950 - 1030  Apply Lean Thnking to Optimize CPV
  • Tara Scherder, Partner, SynoloStats, LLC, USA
    Apply Lean Thinking to Optimize CPV
1030 - 1100  Networking Break
1100 - 1130  Benchmarking
  • Leader: Maurice Parlane, B Tech MIT, Principal/Director, New Wayz Consulting Ltd, New Zealand
  • Brandon Pollack, Process Engineer, Pharmaceutical Manufacturing Science and Technology, Bristol-Myers Squibb, USA
    BMS Equipment Robustness
1130 - 1210  Application of the Lifecycle Approach to PV in Generic and Contract Manufacturing
    1210 - 1310  Lunch
    1310 - 1410  Stage 3a Heightened Monitoring and Testing Decisions - Application to a Post PPQ Scenario: Small Group Exercise
    • Leader: Joanne Barrick, RPh, Advisor, Global Validation Support, Eli Lilly and Company, USA
      Stage 3a Heightened Monitoring and Testing Decisions – Application to a Post PPQ Scenario - Small Group Exercise
    1410 - 1450  PV for Accelerated/Breakthrough Programs
    1450 - 1530  Process Validation in the Context of Continuous Manufacturing Processes
    1530 - 1600  Networking Break
    1600 - 1625  PV for Packaging for Oral Solid Dosage Products: ISPE Draft Discussion Paper
    1625 - 1655  Packaging Validation for an Oral Solid Dosage Bottle Filling Process: A Case Study
    • Christopher Carney, Associate Director, Global Packaging Development , Bristol Myers Squibb, USA
      Packaging Validation for an Oral Solid Dosage Bottle Filling Process: A Case Study
    1655 - 1710  Q&A
    1710 - 1730  Closing Remarks and Next Steps
      1730 - 1830  Combined Reception
      1830 - 2000  Statistical Tools for Process Validation: A Refresher
      1830 - 2000  Open Forum on Draft EMA Reflection Paper on Statistical Methodology
      • Moderator: Yijie Dong, Director, Bristol Myer Squibb Co., USA
      • Moderator: Mark Johnson, Senior Principal Statistician, Research, AbbVie, USA
      • Moderator: Lori Pfahler, Executive Director, Merck & Co Inc, USA

      Thursday, 14 September

      0830 - 0840  Welcome and Opening Remarks
      0840 - 0915  ICH Q12: Development and Impact
        0915 - 0950  PV Lifecycle Implementation: Successes and Opportunities
          0950 - 1010  Networking Break
          1010 - 1035  Industry Maturity in the Assessment and Use of Process Capability
          1035 - 1105  PV Lifecycles Implementation Progress in Europe and Asia
          • Maurice Parlane, B Tech MIT, Principal/Director, New Wayz Consulting Ltd, New Zealand
          1105 - 1140  FDA View of the Maturity of PV Lifecycle Implementation
          • FDA Representative, US FDA, USA, Invited
            FDA View of the Maturity of PV Lifecycle Implementation
          1140 - 1200  Panel Discussion
          1200 - 1300  Lunch

          Early Registration Discount Ends on 20 August!

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          Process Validation and Process Validation Statistics Conference

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          Featured Speakers

          Bethany Rexing Photograph
          Bethany Rexing
          Manager
          Eli Lilly and Company
          Daniel Boggs Photograph
          Daniel Boggs, PhD
          Engineering Consultant
          Fresenius Kabi
          Jonathan Wade Photograph
          Jonathan Wade, PhD
          Research Scientist
          Eli Lilly and Company
          Robert IeversPhotograph
          Robert Ievers
          Director
          Merck & Co.
          Thomas Zahel Photograph
          Thomas Zahel
          Consultant
          Exputec GmbH

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