Computer System Validation for Pharmacometrics (Ep. 16)

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Clinical Pharmacology Podcast with Nathan Teuscher not yet transcribed

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Recorded25 Dec 2023

Publisheranchor.fm ↗

Handlerec:9442484

Show notes

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 Copyright Teuscher Solutions LLC All Rights Reserved

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