Leveraging Statistics in the Process Validation Lifecycle

July 27, 2017



The ISPE Process Validation Statistics Conference has become a converging point for statisticians and those skilled in the use of statistics to reflect on past practices, describe current trends, and explore future challenges. The conference serves as a technical forum to get your most pressing questions on the application of statistics in the process validation lifecycle answered.

This year’s event will include numerous opportunities to have your voice and opinions heard, and to actively explore solutions to current issues. This conference provides the unique chance for attendees to influence the future expectations for the use statistics in the various stages of the lifecycle approach to process validation. It will begin with Wednesday night’s discussion of the new reflection paper from the EMA Biostatistics Working Party on comparability methods and criteria for use throughout the process validation lifecycle, where your concerns on the draft paper will be captured and formally offered to the working party through ISPE. Also on Wednesday night, a refresher training on Statistical Tools for Process Validation will be held which is intended for non-statisticians.

The keynote session will be given by Dr. Kit Roes from the University Medical Center Utrecht. As a representative for the EMA Biostatistics Working Party that drafted the reflection paper, he will share with us the background and drivers for this paper. You will have an ongoing opportunity to actively participate using electronic polling software throughout the conference. The electronic polling will be used to select the problems to solve in work groups in the interactive session, “Hot Topics in Application of Statistics for Process Validation.” Benchmarking results will be captured and shared with attendees, allowing you to gauge your progress and use as a reference when developing and/or revising your company’s approach.

New this year will be two sessions on analytical method development and validation and the links to process validation. In addition, the conference will have several exciting sessions on statistical applications in the process validation lifecycle including:

  • Process parameter criticality assignment
  • CPV/control strategy
  • Risk assessment
  • Contract manufacturing

In addition to the sessions, the conference will also include talks from two FDA regulators. You will learn from and be able to ask questions of Milva Melendez presenting on Statistics in the Process Validation Lifecycle, and Arwa El Hagrasy presenting on Continuous Manufacturing.

View the complete education program to see what you’ll experience at the conference.

Double the Learning and Increase Your Savings!

Get the most of your experience by also attending the 2017 ISPE Process Validation Conference, which takes place right before the Process Validation Statistics Conference. Save an additional 25% by registering for both conferences.