FDAnews Announces — New Management Report — Effective 483 Responses: FOCUS on CAPA Violations

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Regulatory law expert Glenn Demby has culled the best, and some of the worst responses the FDA has received. In the new management report Effective 483 Responses, he’ll walk readers through which responses were good and which were not, so they can make their answers the best they can be.

Effective 483 Responses:
FOCUS on CAPA Violations
**An FDAnews Management Report**
http://www.fdanews.com/Effective483Responses    

Who does not hate sitting down to write a company’s response to a 483? Wouldn’t it be helpful to know what other companies wrote, especially for CAPAs?

Well, now manufacturers can with Effective 483 Responses: Focus on CAPA Violations, a new management report from FDAnews.

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

When manufacturers have only 15 days to respond to the FDA (and get it through all those internal reviews), they need all the help they can get.

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

Even if a manufacturer hasn’t received a 483 on a CAPA, it’s not a bad idea to take a look at what FDA investigators are looking for and how to respond correctly. It might help with on-the-spot answers at the next inspection.

This management report will provide the following:

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

Who Will Benefit:

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

FDAnews Management Report Details:
Effective 483 Responses:
FOCUS on CAPA Violations
Price: $397
http://www.fdanews.com/Effective483Responses    

Easy Ways to Order:
Online: http://www.fdanews.com/Effective483Responses            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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