June 2nd, 2022 | 35:14

How to Write Compliance Responses to the FDA that Builds Trust

This Advanced Compliance Writing Webinar will teach you how to draft responses to enforcement actions, including 483’s, in a manner that will positively address inspector and supervisor concerns. Understanding what causes red flags to be raised and how to develop and maintain trust through your written responses are the ultimate goals of this session. Specific examples will assist you to develop good drafting skills.

Learn how to propose corrective actions to address FDA concerns including restating the violation to your advantage, the use of corrective action key words and what the key elements of a response are to build confidence and trust with the FDA. We’ll include some compliance writing exercises to hone your skills.

You’ll walk away from this session with a better understanding of how to draft responses which elicit FDA trust including:

  • Understanding FDA’s mindset
  • Ensuring FDA’s expectations are met
  • Structuring an effective response
  • Maintaining FDA’s trust going forward

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