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2021 ISPE Annual Meeting & Expo

Concurrent Session: QRM/CQV - Best Practices and Lessons Learned

Nov 1, 2021 1:00pm ‐ Nov 1, 2021 2:30pm


Concurrent Session: QRM/CQV - Best Practices and Lessons Learned|This session will address the development of standardized templates, application of risk-based concepts, and examples of implementation by Bayer and Amgen.  In addition, the session will provide case studies demonstrating design with qualification in mind.  Join the discussion and hear more about best practices, industry use-cases, and utilizing a system of lean integrated CQV.

Session Leader(s):


  • Midhu Varghese, Associate Director, Commissioning & Qualification, AbbVie, Inc.
  • Joerg Block, PhD, GMP Compliance Engineering, Bayer AG PH-PS Engineering
  • David Macdonald, Principal Engineer, Hyde Engineering and Consulting

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