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    CaseLab

    What FDA QMSR requires from your QMS and how to get ready

     

    By joining this showcase, you will discover:

    • How a modern eQMS can support QMSR readiness without increasing operational burden.
    • How to move from reactive compliance to structured, inspection-ready operations.
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    A practical session on what QMSR means in practice and how to prepare

    In this CaseLab session, independent expert Jennifer Mascioli will break down what QMSR means in practice, where companies are most at risk, and how to translate these requirements into sustainable, inspection-ready operations.

     

    What you'll learn in this session:

    • Where companies are already failing under QMSR during early inspections.
    • What FDA inspectors are focusing on the first wave of QMSR enforcement.
    • How to close gaps in risk management, documentation, and QMR processes.

     

    Speakers

    Angel CaseLab

    Angel Buendia

    Knowledge Manager
    at Scilife

    CaseLab-Jennifer

    Jennifer Mascioli

    Founder and CEO at JMT Compliance Consulting

    CaseLab-Santosh

    Santosh Paragond

    Account Executive