Form 483 and Warning Letter Responses Critical Component of the FDA's New "Get Tough" Enforcement

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The FDA got a lot tougher on Sept. 15 when it implemented a new Form 483 response program. Big players are getting snared already. But you can sidestep the FDA’s net — with secrets of crafting response letters that work. Read on ...

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You just received a Form 483 from the FDA — and have 15 business days to respond. What now?

Submit a carefully crafted response letter within 15 days and the FDA will immediately conduct a detailed review of your response — to determine whether to issue a warning letter.

Send a weak response letter — or submit it late — and you can count on a warning letter and delays in the process of getting your closeout letter.

That’s what happened to Genzyme. Their response to a Form 483 fell short of FDA expectations. Then the company made things worse, announcing the FDA was satisfied with its CAPAs ... as the FDA was planning a reinspection!

Genzyme is not alone. Since the FDA announced tough new enforcement policies in September, the agency has come down hard on Caraco and Teva, to mention just two high-profile cases.

Too bad those companies didn’t learn the secrets of submitting successful response letters before it was too late.

But you can. In just 90 minutes.

Mark your calendar for a webinar on writing response letters that work — a comprehensive checklist of do’s and don’ts.

  • Understanding the 6 new FDA “get tough” enforcement policies
  • 6 techniques to successfully respond to 483s in 15 days or less
  • Warning letter and consent decree trends
  • How to evaluate the intent of the observation
  • The importance of CAPA in obtaining a closeout letter
  • 4 components every CAPA must include

You’ll discover how to avoid the mistakes Genzyme, Caraco and Teva made, with case studies of each company’s missteps. Plus you’ll hear dozens of actionable recommendations to protect your company in uncertain times.

This webinar is totally interactive, with the opportunity to email all your questions for answers by the time the session ends.

Attend in the comfort of your own office without ever leaving your desk. And take advantage of one low registration price per facility by signing up every colleague who has a hand in quality, GMP, risk management, inspections and compliance.

Genzyme, Caraco and Teva will survive their bruises ... now you can learn how to avoid them in the first place. Register today.

  • Compliance officers
  • General/corporate counsel
  • Executive management
  • Quality assurance
  • Risk management specialists
  • Outside attorneys
  • Regulatory/legislative affairs professionals
  • Department supervisors/directors

Dr. Marla Phillips, Director of Med-XU at the Xavier University Leadership Center, has more than 13 years’ experience ranging from Head of Quality at Merck to global consulting with former FDA inspectors, and has served as a liaison between industry and the FDA on quality issues and manufacturing compliance. Through her strong relationships with FDA, Dr. Phillips has a deep understanding of the challenges faced by regulated drug and device manufacturers and a clear vision of FDA expectations. She has helped organizations write impactful Form 483 and warning letter responses and continues to conduct mock PAI and GMP inspections for companies here and abroad.

Register now!

Date: Jan. 18 – Feb. 5, 2010
Location: Your office or conference room (no need to travel!)
Time: Anytime

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