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Key Considerations for Process Validation and Tech Transfer

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This webinar explores the evolution in process validation regulations, to the 3-stage approach used today, and how to harness product and process knowledge through each stage. First, the requirements of each stage and how each stage of PV interact with each other is addressed. Then, we will discuss the how to avoid the common pitfalls in technology transfer and focus on creating flawless knowledge transfer as part of the tech transfer process.

 

Top Ten Reasons to Attend

  1. Learn how PV regulations have evolved
  2. Know the requirements for each stage of PV
  3. See examples of how to capture product/process knowledge using a risk management processes
  4. Learn how to document the justification for number of PPQ lots
  5. Document stage 3 of a CPV plan
  6. Develop a plan for successful tech transfer
  7. Create a gap analysis for tech transfer projects to enable successful transfer
  8. Document an effective tech transfer plan
  9. Understand the importance of knowledge management
  10. Turn tech transfer challenges into opportunities for your site

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Speakers

Phil Jarvis

EU C&Q Lead, Abbvie

Mr. Jarvis is an experienced team leader with over 15 years of experience in all areas of validation including; process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation. Through strategic thinking, he has success in steering and managing complex validation projects within the medical device and pharmaceutical industries ,and currently is the European lead for C&Q for Abbie.