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Effective Responses to FDA 483’s and Warning Letters

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Effective Responses to FDA 483’s and Warning Letters

Speaker : J. Lawrence Stevens, RAC

When you receive an FDA-483 after your FDA inspection, how you respond can determine if FDA will send you a Warning Letter. If you receive an FDA Warning Letter citing violations, how you respond can determine if FDA will seek a Voluntary Injunction effectively putting you out of business.

In this webinar we will discuss the correct way to formulate your response to demonstrate to FDA that you have a complete understanding of the issues, and the corrective actions will prevent a recurrences of the violations.

If your responsibility is responding to FDA-483’s and Warning Letter you must become familiar with the type of response that will satisfy FDA.Too often firms send incomplete (not well thought out) response to FDA either correcting and individual problem, not providing objective evidence, and/or providing unreasonable correction dates. It his happens with an FDA -484 FDA will either visit you again very soon, or you will get a Warning Letter. A poor response to Warning Letter can be disastrous.

  • FDA policies on creating the FDA-483
  • FDA policy on issuing Warning Letters
  • Review example of Warning Letter Responses.
  • How to manage the creation of an effective response
  • What is an FDA-483?
  • Why does FDA issue Warning Letters?
  • How do you formulate an effective response?
  • Review recent FDA Warning Letter citations
  • How to determine if FDA is satisfied with your response.
  • QA Manager, Director or VP’s
  • Regulatory Affairs Managers, Director, or VP
  • Operations Managers, Directors or VP
  • Corporate Compliance Personnel.
  • Regulatory Consultants to the medical device industry

Please Click Below Link For Registration:

https://www.demystifiedsolutions.com/trainingDetails/Effective-Responses-to-FDA-483%E2%80%99s-and-Warning-Letters-DEMY050159


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