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    Computer System Validation for Pharmacometrics (Ep. 16)

    Computer System Validation for Pharmacometrics (Ep. 16)

    FromClinical Pharmacology Podcast with Nathan Teuscher

    Start listeningView podcast show

    Computer System Validation for Pharmacometrics (Ep. 16)

    FromClinical Pharmacology Podcast with Nathan Teuscher

    ratings:
    Length:
    30 minutes
    Released:
    Dec 25, 2023
    Format:
    Podcast episode

    Description

    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
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    Copyright Teuscher Solutions LLC
    All Rights Reserved
    Released:
    Dec 25, 2023
    Format:
    Podcast episode

    Titles in the series (27)

    I discuss clinical pharmacology and pharmacometrics topics from the perspective of drug development scientists. I share my expertise and knowledge about designing and conducting clinical pharmacology studies and discuss how to analyze the data using the most effective approaches. I draw from my experience of over 20 years working in drug development organizations and consultancies.