Form 483 and Warning Letter Responses - Webinar CD/Transcript

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Form 483 and Warning Letter Responses

It’s vital to know what’s triggering citations and what to do if you’re hit with a Form 483.

How can you quickly become an expert on how to mount the effective, timely responses needed to keep warnings from escalating?

Industry expert Gordon Richman has the answers. In this 90-minute presentation he provides examples, industry trends and actionable recommendations that will prove to be invaluable.

You will learn:

  • How to stay out of the crosshairs of the new FDA “get tough” enforcement
  • Warning letter and consent decree trends in your industry
  • Techniques to successfully respond to Form 483s in 15 days or less
  • How to evaluate the intent of the observation
  • What the FDA expects when reviewing Form 483 and warning letter responses

Order today and develop best practices for responding to 483s and warning letters.

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

Gordon B. Richman, Vice President and Regulatory Compliance Counsel, Danaher Diagnostics Platform at Beckman Coulter
Mr. Richman joined Beckman Coulter in 2012. He brings a unique background and over 25 years of regulatory, legal, and corporate management experience, including more than 10 years in increasingly responsible senior management positions with leading pharmaceutical and medical device companies.