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Sessions at 2-day In-person Seminar on “Software Validation for the New FDA Inspections” in San Diego on Thursday 19th September Thursday

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  • Day 1 – Agenda

    by David Nettleton

    Lecture 1: Introduction to the FDA
    Lecture 2: 21 CFR Part 11 - Compliance for Electronic Records and Signatures
    Lecture 3: HIPAA Compliance for Electronic Records
    Lecture 4: The Five Keys to COTS Computer System Validation
    Lecture 5: The Validation Team

    At 9:00am to 6:00pm, Thursday 19th September

    In DoubleTree Hotel San Diego Downtown