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: Brad Berkowicz, Director, Drug Product Technical Services, Shire, USA
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 - 1440  Translating Stage 1 Data to NOR, PAR and the Control Strategy: Small Group Exercise
  • Tara Scherder, Partner, SynoloStats, 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, Ph.D, 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 - 1610  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)
1610 - 1650  Development of Attribute Process Validation Sampling Plans
  • James Wright, PhD, Senior Principal Statistician, Shire Pharmaceuticals, USA
    Development of Attribute Process Validation Sampling Plans
1650 - 1715  Addtional 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, 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
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 - 1630  PV for Packaging for Oral Solid Dosage Products: ISPE Draft Discussion Paper
  • Maneesha Altekar, PhD, Principal QA Statistician, AstraZeneca, USA
    PV for Packaging for Oral Solid Dosage Products: ISPE Draft Discussion Paper
1630 - 1710  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
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 - 0910  ICH Q12: FDA Perspective
    • Ashley Boam, Director, Office of Policy for Pharmaceutical Quality, OPQ, FDA/CDER/OPQ/OPPQ, USA, Invited
    0910 - 0950  Clinically Relevant Specifications: Industry Perspective
    • Christine Moore, PhD, Global Head and Executive Director, Merck & Co., USA, Invited
    0950 - 1015  Networking Break
    1015 - 1045  Industry Maturity in the Assessment and Use of Process Capability
    1045 - 1125  Regulatory Session
      1125 - 1200  Determining Process Capability and Determining Process and Monitoring Maturity
      • Frank Wackes, Consumer Safety Officer, FDA/CDER/OMPT/OPQ/OPF/DIA/IABI , USA, Invited
      1200 - 1300  Lunch

      Register Early!

      Register before 1 August to take advantage of the early bird rate and save!

      Get an additional 25% discount when you register for both Process Validation and Process Validation Statistics Conference, taking place right after! 

      Featured Speakers

      Dr. Qiu Photograph
      Zhihou "Peter" Qiu, PhD
      Branch Chief
      Division of Inspectional Assessment
      FDA/OPF/OPQ/CDER
      Ranjani Prabhakara Photograph
      Ranjani Prabhakara, PhD
      Team Leader
      Office of Compliance, Division of Drug Quality II
      FDA/CDER/OMQ
      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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      Presentations & Attendee Roster

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