Effective 483 Responses: Focus on CAPA Violations

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Effective 483 Responses
Focus on CAPA Violations

Everyone breathes a sigh of relief when the FDA investigators depart.

But if they left behind a Form 483 pointing out deficiencies and noncompliances, that’s when the work really starts.

The good news is that a well-reasoned response can help a company side step a warning letter or worse. The bad news is that the agency gives you only 15 business days to pull it together.

Regulatory law expert Glenn Demby has culled the best — and some of the worst — responses the FDA has received to 483s. He’ll walk you through which responses were good and which were not, so you can make your answers the best they can be.

Glenn will show you the FDA's exact CAPA observations in each 483 and put them side-by-side with the company’s response. You’ll see how firms handled particular issues, especially the tone and language they used.

If your company hasn’t received a 483 with CAPA observations, you can match your systems with those that have and ensure that all gaps are closed before your next inspection.

This management report, Effective 483 Responses: Focus on CAPA Violations, will provide the following:

  • Lessons learned from past 483 responses — both good and bad
  • The confidence to respond appropriately to your next 483
  • The ability to respond within the 15-day timeframe
  • An insight into how to avoid 483s by implementing solutions others have used

Remember, you have only 15 days to respond to a 483. Most of that time will go toward bringing your CAPA program into compliance. Don't waste a second trying to figure out how to communicate those plans in a way that will convince the FDA you are focused on improvement and committed to quality. Learn from those who have been there.

 

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Who Will Benefit

  • Quality control
  • Regulatory affairs
  • Legal counsel
  • Executive officers

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