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    AI meets ALCOA+: a new data integrity challenge for GxP

    Explore AI’s impact on data integrity, ALCOA+ and how to stay in control.

    Agenda

    05:30
    The first FDA warning letter on AI

    10:10
    27 years of rules, 2 years of AI

    22:30
    Why AI breaks CSV

    41:15
    Annex 22, GAMP 5 and ALCOA++

    48:50
    The eight inspector questions

    56:45
    Closing Remarks + Q&A

    AI is increasingly becoming part of regulated workflows. But when it produces, influences, or makes decisions based on GxP data, data integrity and AI governance become more complex. How do ALCOA+ principles apply to AI? Who remains accountable for its decisions? And how can Quality teams stay in control?  Join Harsh Thakkar for a practical training session exploring AI’s impact on data integrity, governance, and Quality oversight in GxP environments, including new risks, traceability, and effective human oversight

    You’ll learn:

    • How AI changes GxP workflows and how to assess its risks.
    • How ALCOA+ applies when AI produces or influences regulated records.
    • New data integrity risks, AI failure modes, and maintaining traceability.
    • What effective QA oversight looks like, including human vs. AI decision-making.