FDA Chief Counsel Report – How to Deal With and Avoid Warning Letters | Archived Recording| Bradshaw

FDA Chief Counsel Report – How to Deal With and Avoid Warning Letters | Archived Recording| Bradshaw

April 17th, 2013 // 2:05 am @

FDA Chief Counsel Report – How to Deal With and Avoid Warning Letters | Archived Recording| Bradshaw

Archived Recording – CD and download available!

Getting an FDA warning letter can cost you big. Your company can receive bad publicity and lose business. Your reputation suffers, and in some cases, your firm may even have to deal with FDA’s Office of Criminal Investigation.

Join us and learn from former FDA Chief Council Sheldon Bradshaw. Learn about recent warning letters, including:
- Gilead Sciences
- Beckman Coulter
- H&P Industries (this one is a real nightmare)

Learn how to avoid the huge trouble that a warning letter can cause. Learn about FDA’s greater enforcement efforts and warning letter changes: setting post inspection deadlines, speeded up warning letter process, working more closely with regulatory partners, implementing warning letter close out process, and much more.

Note: All Expertbriefings.com Webinars are eligible for 1.0 CEU towards RACS Certification and 0.1 RU towards ASQ Certification.

PLUS, ask your warning letter questions to the former FDA Chief Counsel in a 15 minute Q/A session!

What You Will Learn in This FDA Warning Letter Webinar:

  • Set Post-Inspection Deadlines
  • Speed Up Warning Letter Process
  • Work More Closely with Regulatory Partners
  • Prioritize Follow Up on Warning Letters
  • Respond to Public Health Risks Immediately
  • Implement Warning Letter Close Out Process

Also learn from Bradshaw:

  • What is the new time frame in which companies must respond to a 483 before getting a warning letter?
  • How to respond to warning letters and untitled letters?
  • Will FDA send you a warning letter before taking action?
  • What are the criteria for FDA taking enforcement action WITHOUT sending a letter first?
  • How to avoid and recover from a warning letter?
  • What proactive plans should be in place to avoid warning letters?
  • How quickly can the Office of Chief Counsel take you to court after a warning letter is issued?

Attendees will receive these free gifts:

  • Six-month subscription to SMARTERCOMPLIANCE™ newsletter by Cerulean Associates ($129 value)
  • Expert, easy-to-grasp guide on Quality-by-Design, (QBD) by Cerulean Associates
  • “Lean Compliance for Midsized Companies” (from Journal of GXP Compliance, January 2008)

About the Presenter:

In October 2007, Sheldon Bradshaw joined Hunton & Williams LLP as a partner and co-chair of the firm’s Food and Drug Practice Group. Mr. Bradshaw came to the firm from the U.S. Food and Drug Administration (FDA), where he served as Chief Counsel. As Chief Counsel, Mr. Bradshaw was responsible for providing legal advice to the Secretary and Deputy Secretary of the U.S. Department of Health and Human Services and to the FDA’s senior leadership – including the Commissioner, the Deputy Commissioners and the Directors of the various FDA Centers – on issues related to drugs, biologics, medical devices, food, animal feed and drugs, cosmetics, dietary supplements and other products regulated under the Federal Food, Drug and Cosmetic Act and the Public Health Service Act. In addition, he oversaw all FDA-related litigation and reviewed and approved every significant regulation and guidance document promulgated by the FDA and every significant warning letter issued by the FDA. Prior to his service at the FDA, Mr. Bradshaw held several senior positions at the U.S. Department of Justice where he, among other things, provided advice to FDA and testified before Congress on matters under the FDA’s jurisdiction. At the firm, Mr. Bradshaw advises clients in the same areas in which he worked while Chief Counsel of FDA.





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