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2-day In-person Seminar on “Software Validation for the New FDA Inspections” in San Diego  schedule

Thursday 19th September 2013

  • 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

Friday 20th September 2013

  • Day 2 – Agenda

    by David Nettleton

    Lecture 6: Ten-Step Process for COTS Computer System Validation
    Lecture 7: How to Write Requirements and Specifications
    Lecture 8: How to Conduct a Hazard Analysis/Risk Assessment-Exercise
    Lecture 9: Software Testing
    Lecture 10: System Change Control
    Lecture 11: Cost Reduction Without Increasing Regulatory or Business Risk
    Lecture 12: Q & A

    At 9:00am to 6:00pm, Friday 20th September

    In DoubleTree Hotel San Diego Downtown