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

At the 4th Annual ISPE Process Validation Statistics Conference learn how to leverage 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 and generics development and share your thoughts with the working party. Dr. Kit Roes, will be there to reflect on your questions.

Discussion Group Breakouts:
Engage in quality dialogue with fellow statisticians and get valuable insights on topics such as:

  • Transitioning from Stage 3A to 3B?
    • Extended testing in 3A
    • Specific criteria vs number of batches
  • Statistically-based acceptance criteria during PPQ
    • Types of parameters and plans
  • Leveraging Stage 1 data in Stages 2 and 3
  • Stage 3 Monitoring
  • Interesting regulatory feedback in regards to the implementation of the lifecycle approach
  • Withdrawal of FDA Blend Guidance and issues around blend uniformity
  • Tools for acceptance criteria for dissolution
  • Challenges around application of lifecycle approach to analytical processes

 2 Conferences, 1 Location

Sharpen your Process Validation knowledge by taking advantage of the 2017 Process Validation Conference which happens right before the Process Validation Statistics Conference.  Plus by registering for both conferences, we'll give you 25% off!

Attendees who register for both conferences will have access to a networking reception and two concurrent sessions in the evening on 13 September; Statistics for Beginners and a Statistics Forum, and a half-day combined regulatory session on 14 September.

 Add to your Calendar » Register Now »

 Thank you to our Program Committee!

Tara Scherder Photograph
Tara Scherder
Partner, SynoloStats
Lori Pfahler Photograph
Lori Pfahler
Executive Director, Merck
Joanne Barrick Photograph
Joanne Barrick
Advisor Global Validation Support
Eli Lilly and Company
Jennifer Walsh Photograph
Jennifer Walsh
Director Robustness & Validation
Bristol-Myers Squibb
Maneesha Altekar Photograph
Maneesha Altekar
Principal QA Statistician
James Bergum Photograph
James Bergum
Statistical Consultant
Mark Johnson Photograph
Mark Johnson
Senior Manager
Daniel Peng  Photograph
Daniel Peng
Kimberly Vukovinsky Photograph
Kimberly Vukovinsky
Senior Director
Nonclinical Statistics


Featured Speakers

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: