Beyond the Basics: Mastering Compliance Writing for FDA 483s and Warning Letters

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

• Tips for Writing an effective response to FDA 483’s or WL
• 10 necessary elements of response
• Effective word choices
• How to disagree with inspector observations
• Restating the violation to your advantage