Clinical Pharmacology Podcast with Nathan Teuscher

Computer System Validation for Pharmacometrics (Ep. 16)

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This is the last podcast for 2023. Thank you for listening throughout the year! In today’s episode I talk about computer system validation for pharmacometrics. I review my experience with validation in multiple companies over 20 years and discuss what auditors and FDA inspectors want to see.


Links discussed in the show:

  • Computer system validation guidance for medical devices
  • Computer systems used in clinical trials
  • Computer system assurance guidance for medical devices
  • EMA guidance on computer systems and electronic data in clinical trials
  • You can connect with me on LinkedIn and send me a message
  • Send me a message
  • Sign up for my newsletter


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    Clinical Pharmacology Podcast with Nathan TeuscherBy Nathan Teuscher
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