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  • Essential Last Minute Preparation for an Imminent FDA

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Wednesday - Jul 10, 2013 10:00 AM
  • End Time:
  • Wednesday - Jul 10, 2013 11:00 AM
  • Location:
  • Online
  • This webinar on preparing for FDA inspections will present simple but powerful tools, with real world examples on how to prepare for an impending FDA inspection. You will learn what essential last minute preparation activities can be done and others that should be avoided.

    Why Should You Attend:

    Whether FDA will be arriving in three days, or three weeks, a pre-announced inspection provides one measure of certainty: how much time you have remaining to prepare.

    Now is the time to act so that you stay ahead of FDA expectations and prevent a 483 finding that could have been avoided. During this session, you will learn:

    - What document updates, memorandums and reports can be created to address potential gaps within the application of your Quality System.
    - How to prepare the inspection support team as well as the greater organization for proper behavior and conduct during an FDA inspection.
    - How to implement a record collection and presentation strategy, so that you are not surprised by documents provided to the inspector.
    - How to manage the pace of the inspection so that you, not the inspector, are in the driver’s seat.

    Also covered are what last minute activities that should be avoided. Few things can change the tone of an inspection than presenting 'wet ink' records that appear to an auditor to have been created for the inspection.
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