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

4th Annual ISPE Process Validation Statistics Conference
Leveraging Statistics in the Process Validation Lifecycle

This exceptional forum has become a converging point for statisticians and those skilled in the use of statistics to reflect on past practices, discuss current trends, and consider future challenges. You'll have the opportunity to interact with regulatory experts and leading practitioners as they share their current thoughts on the relationship of statistics, validation decisions, and patient risk.

This year's conference will expand your knowledge on:

  • Regulatory perspectives on the application of statistics in the PV lifecycle
  • Leveraging the Control Strategy during Continued Process Verification (CPV)
  • Quality by Design (QbD) approach in analytical method development and validation
  • Statistical approaches for process parameter criticality assignment in Stage 1
  • Opportunities and challenges for statisticians in risk assessment throughout the product lifecycle
  • Statistical considerations for contract manufacturing

Keynote Session: 

Kit Roes

The EMA (Draft) Reflection Paper on Statistical Methodology for the Comparative Assessment of Quality Attributes 

Kit Roes, PhD, Professor of Clinical Trial Methodology, University Medical Center Utrecht, Chair of the Working Group Methodology, Dutch Medicines Evaluation Board, Observer in the EMA Biostatistics Working Party

Statistical tools for Process Validation: A Refresher
This session is designed for statisticians and professionals using statistics, desiring a refresher in preparation for understanding of applications presented in PV Stats conference.


Open Forum on Draft EMA Reflection Paper on Statistical Methodology
Take advantage of this opportunity to explore current regulatory considerations on statistical aspects of pre and post-manufacturing change, biosimilar development, as well as generics development and have your comments shared with the working party.  Dr. Kit Roes, keynote speaker will be there to answer your questions.

Discussion Group Breakouts: Engage in quality dialogue with fellow statisticians and get valuable insights.


  • Transitioning from Stage 3A to 3B?
    • Extended testing in 3A
    • Specific criteria vs number of batches
  • Statistically-based criteria for PPQ
    • Types of parameters and plans
  • Leveraging Stage 1 data in Stages 2 and 3
  • Interesting regulatory feedback in regards to the implementation of the lifecycle approach
  • Issues around blend uniformity
  • Acceptance criteria for dissolution

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
Arwa El Hagrasy, PhD Photograph
Arwa El Hagrasy, PhD
Acting Quality Assessment Lead
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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Presentations & Attendee Roster

Conference Attendees: