Latest FDA Warning Letter Trends for 2011 – FDA Chief Counsel Update | Sep 13, 2011

Join us and learn from former FDA Chief Counsel Sheldon Bradshaw about FDA’s greater enforcement efforts and warning letter changes: setting post inspection deadlines, speeding up warning letter process, working more closely with regulatory partners, implementing warning letter close out process, and much more.

  • 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?

Latest FDA Warning Letter Trends for 2011 | FDA Chief Counsel Update
Sheldon Bradshaw, former FDA Chief Counsel
September 13, 2011 -12-1 PM EDT
Price: $399 ($50 Off with Discount Code 101250)
Click here to view more details >>

Attendees will receive these free gifts:

  • Subscription to FDA Digest – 483/warning letter e-newsletter
  • 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.

Price: $399 ($50 Off with Discount Code 101250)

Click here to view more details >>

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence.

Latest FDA Warning Letter Trends for 2011 | FDA Chief Counsel Update
Sheldon Bradshaw, former FDA Chief Counsel
September 13, 2011 -12-1 PM EDT

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