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Legal aspects of FDA regulatory Compliance: Preparing for an FDA Facility Inspection and Responding to a 483 Letter

May 18, 2020


In addition to evaluating data from adverse event reports, the bulk of FDA’s regulatory enforcement comes from its facility inspections and resulting 483 reports. This practical webinar will cover numerous aspects of preparing your drug or medical device establishment for a successful FDA facility inspection and responding to any post-inspection 483 letters. The key to a successful inspection strategy is adequate preparation and implementing the inspection plan before FDA knocks on your door. Attendees will learn:
    • What to expect during the inspection;
    • Strategies for preparing for an inspection;
    • What to expect after the inspection;
    • Strategies for responding to any deficiencies noted in a 483 report;
    • Potential product liability issues stemming from a 483 report.