Science and Regulatory Affairs

Process Validation Interest Group

Group Leader :
Scott Bozzone, Ph.D.
Pfizer, Inc.
Email: Scott.Bozzone@pfizer.com

To provide an on-going forum for the exchange and dissemination of information and ideas for the purpose of education, innovation, and compliance related to the validation of critical processes and those activities which support the validation of critical processes.

The interest group should be a forum for presenting and discussing issues and trends in validation. These discussions should result in a better understanding of PDA member needs. This in turn results in better programs, more useful publications, and appropriate areas of advocacy.

Announcement

Dear Process Validation Interest Group Member:

This year at the PDA Annual Meeting on Monday, April 16 at 4:00 -5:30 PM we will have our IG session.  Process Validation continues to be a very active area, with many conferences covering the FDA’s Guidance and international regulatory, intense compliance and inspectional activities.   

We have the following agenda planned:

  • Welcome
  • Short Presentation:  2011 Inspectional Observations on Process Validation (from a Sept 2011  FDA presentation , ~ 5 min)
  • Short Presentation:  Challenges in Process Validation at Amgen – Vijay Chiruvolu - Amgen (~15 min)
  • Discussion: Open-floor on topics (~45 - 60 min), For example:
    • Determining the amount of data needed for PPQ or PV, such as number of batches, sampling plans, and acceptance criteria
    • Determining a continued process verification (stage 3, after PPQ) monitoring plan
    • Feedback on risk management effectiveness at your firm in each of the 3 stages of the lifecycle.
    • Other Discussion (open)

Please make an effort to attend the meeting and contribute to an open discussion.

Sincerely,
Scott Bozzone and Hal Baseman
PDA Process Validation Interest Group Leaders

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