FDAnews Announces — Form 483 and Warning Letter Responses Webinar, July 26, 2016

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It’s vital to know what’s triggering citations and what to do if hit with a Form 483. How can manufacturers quickly become experts on how to mount the effective, timely responses needed to keep warnings from escalating?

Form 483 and Warning Letter Responses
**An FDAnews Webinar**
July 26, 2016 — 1:30 p.m. – 3:00 p.m. ET

The inspector leaves and leaves behind a 483.

Now, it’s time got to tell the FDA how it’s going to be fixed.

The more manufacturers know about how to handle 483s, the more power they have to handle things without facing subsequent warning letters or recalls.
Industry expert Gordon Richman has the answers. In this 90-minute webinar he will provide examples, industry trends and actionable recommendations that will prove to be invaluable.

Attendees will learn:

  • The importance of understanding the audience when writing a response
  • Common industry mistakes (approaches to avoid)
  • Guidance for developing the written response
  • Key steps for effectively responding to the FDA
  • How to manage Form 483s and warning letters
  • How to define Corrective and Preventive Actions (CAPA)
  • Whether an effective response to a Form 483 can avert a warning letter

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

Meet the Presenter:
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.

Who Will Benefit:

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

Webinar Details:
Form 483 and Warning Letter Responses
**An FDAnews Webinar**
July 26, 2016 — 1:30 p.m. – 3:00 p.m. ET

$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/form483responses            
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
+1 (703) 538-7665
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