Process Validation Statistics 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 for statistical expectations to support the lifecycle approach to process validation

Detailed Program

Wednesday, 13 September

1730 - 1830  Combined Networking 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
    1300 - 1330  Welcome, Introductions, Agenda for the Day and Benchmarking Session
    • Leader: Lori Pfahler, Executive Director, Merck & Co Inc, USA
      Welcome, Introductions, Agenda for the Day and Benchmarking Session
    • Leader: Tara Scherder, Partner, SynoloStats, USA
    1330 - 1415  Keynote: The EMA (Draft) Reflection Paper on Statistical Methodology for the Comparative Assessment of Quality Attributes
    • Kit Roes, PhD, Professor Clinical Trial Methodology, Netherlands
      The EMA (Draft) Reflection Paper on Statistical Methodology for the Comparative Assessment of Quality Attributes
    1415 - 1500  Analytical QbD - Analytical Variability to Process Variability
    • Kimber Barnett, PhD, Associate Research Fellow, Pfizer, USA
    • Brent Harrington, Director, Pfizer, USA
      Analytical QbD – Analytical Variability to Process Variability
    1500 - 1530  Networking Break
    1530 - 1600  Implementation of Transmission Raman Spectroscopy for At-line Unit Dosage Uniformity Prediction
    • Orlando Mezquita, Regional Statistician, AstraZeneca, USA
    1600 - 1700  Interactive Group Breakouts
    • Leader: Tara Scherder, Partner, SynoloStats, USA
      Interactive Group Breakouts

    Friday, 15 September

    0830 - 0845  Welcome, Agenda for Day 2 and Benchmarking
    0845 - 0925  Report Out from the Interactive Breakout Groups
    • Leader: Tara Scherder, Partner, SynoloStats, USA
      Interactive Group Breakouts – Report Out from the Groups
    0925 - 1005  Application of Statistics in the PV Lifecyle
    • Milva Melendez, Senior Consumer Safety Officer, Inspection Assessment Branch, Office of Surveillance, FDA/OPQ/CDER, USA
      Application of Statistics in the PV Lifecyle
    1005 - 1035  Networking Break
    1035 - 1120  ISPE PV Good Practice Guide including New Statistically Based Criteria for Content Uniformity and ISPE Papers: PV for Packaging and PV for Breakthrough Products
    1120 - 1150  Evolving CPV Trends: Leveraging the Control Strategy
    1150 - 1220  A PV-1 Statistical Approach to Aid Process Parameter Criticality Assignment
    • Kimberly Vukovinsky, Senior Director, Statistics, Pfizer Inc, USA
      A PV-1 Statistical Approach to Aid Process Parameter Criticality Assignment
    1220 - 1320  Lunch
    1350 - 1420  Opportunities and Challenges for Statisticians in Risk Assessment Throughout the Product Lifecycle
    1350 - 1420  A Standardized Approach to Bayesian PPQ Sample Size Implementation Using R-shiny
    • David Enck, M.A., Director, Design To Value & QE, Janssen Pharmaceuticals, USA
    1420 - 1450  Networking Break
    1450 - 1530  Considerations for Continuous Manufacturing Implementation Throughout a Product Lifecycle: FDA Perspective
    1530 - 1600  Statistician's Perspective on Contract Manufacturing
    • James Wright, PhD, Senior Principal Statistician, Shire Pharmaceuticals, USA
      Statistician’s Perspective on Contract Manufacturing
    1600 - 1630  Benchmarking Trends Over the Years for PV Stats| Discussion of Benchmarking Results| Input on Next Steps for the ISPE PV Team

    Register Early!

    Register before 1 August to take advantage of the early registration rates and save! 

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

    Don't Miss a Single Session
    Get the most of your conference experience by passing this along to your statistician colleagues and take advantage of group discounts.

    Featured Speakers

    Milva Melendez Photograph
    Milva Melendez
    Senior Consumer Safety Officer
    Inspection Assessment Branch
    Office of Surveillance
    FDA/OPQ/CDER
    Arwa El Hagrasy, PhD Photograph
    Arwa El Hagrasy, PhD
    Acting Quality Assessment Lead
    FDA/OPF/CDER
    Brent Harrington Photograph
    Brent Harrington
    Associate Director – Statistics Group
    Pfizer Inc.
    Dave Enck Photograph
    Dave Enck
    Director for Design to Value and QE
    Janssen Pharmaceuticals
    James Crichton Photograph
    James Crichton
    Principal Statistician
    Cook Pharmica

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