By Jim Bergum, PhD, President, BergumSTATS, LLC

As a planning team member of the Statistician Forum, I am extremely excited to see that the conference discussion topics are attracting so many statisticians from around the world. Since the issuance of the FDA Guidance on Process Validation in January 2011, the pharmaceutical industry has made considerable progress toward incorporating the lifecycle approach to PV and meeting the expectations contained within the Guidance. Even with the FDA’s guidance, there are significant differences of opinion and various interpretations of the statistical aspects.

The Statistician Forum is the first of its kind and gives us the opportunity to bring ideas and theories together to share, examine and collaborate with the FDA. This forum will start the process of clarifying and finding optimal approaches to the implementation of statistical elements within the FDA PV guidance.

FDA representatives will offer perspectives on the implementation progress and background about rationale for use of statistics being emphasized as part of PV and beyond. The intent of the PV Guidance revision and renewed emphasis on statistical basis for routine release will also be discussed. For example, “Why are USP or ICH UDU criteria not sufficient for release?”

The 2-day forum will include detailed discussions and workshops focused around the most significant implementation challenges related to the application of statistics:

  • Leveraging Stage One Data
  • Determining the Number of Batches for PPQ
  • Determining acceptable criteria and sampling plans
  • Deciding when to re-validate
  • Designing PV Stage 3a Plan
  • Transitioning to PV Stage 3b

In conjunction with these topics, the planning team has devised a strategic list of questions to be address during the two-day intensive. For the full list of the questions and more conference details, click here.

Our intent is to create a dialogue that will clarify expectations for the use of statistics in planning each stage of the Process Validation lifecycle and will influence FDA Guidance, future discussion forums, classroom training, and best practice documents.

I encourage you to continue the conversation with us. If you have questions or challenges you would like to see addressed, please feel free to post them here and we will incorporate them into the Forum discussions.