Responding to 483s and Warning Letters: Strategies for High-Stakes Communications

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Fact: GE Healthcare recently received its third warning letter in a year and a half, this one alleging inadequate CAPA procedures for software packages ... Ranbaxy Laboratories, which has been under scrutiny and received warning letters, now has more than 35 products banned from entering the U.S. ... and the list goes on!

Fines, recalls, injunctions — how you respond to an FDA Form 483 should not be taken lightly. From timing to format to content, each step you take in analyzing the 483 and preparing your response can mean the difference between getting your product successfully to market and denial of access to the market.

With the stakes this high, why would anyone risk offering an unsatisfactory response? Yet it happens all the time ... poorly planned responses often result in warning letters stating the information was inadequate, incomplete, poorly written or unsatisfactory — and can lead to even bigger penalties down the road.

You can be confident in your response if your company receives a 483 when you sign up for this Encore presentation. Noted attorneys Fredrick H. Branding and Cathy L. Burgess will present best practices and lessons learned from decades of representing drug, device and biologics manufacturers. You'll walk away knowing how to assess the FDA's concerns and respond appropriately to avoid making common mistakes that result in warning letters. They'll analyze the language from actual 483 and warning letter responses and discuss why the response given was good or unsatisfactory.

These experts will thoroughly examine:

  • How to analyze a 483 or warning letter — even when it isn't obvious what the FDA is expecting
  • 10 essential dos and don'ts when writing your response to the FDA
  • The proper structure of a response — the FDA is less likely to miss the good things you're doing if you provide the format they want to see
  • Five common mistakes to avoid — now is not the time to wave a red flag
  • The significance of making and keeping FDA commitments — showing good faith can go a long way
  • Why developing timelines for corrective action plans is vital — it's not just what you do but when you do it
  • The importance of supporting documentation — if you can't prove it, you didn't do it

Register now to listen to Responding to 483s and Warning Letters: Strategies for High-Stakes Communications. You'll get an opportunity to ask your toughest questions during the Q&A session.

This presentation is a must for professionals in drug, biologic and device companies, including:

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

Frederick H. Branding is a member of the Life Sciences Health Industry Group at the law firm Reed Smith, practicing in the area of healthcare regulatory law. A registered pharmacist, Fred has extensive experience in pharmaceutical, food, drug, device and cosmetic regulatory compliance and enforcement issues. His experience includes assisting medical products manufacturers in responding to government inspections, warning letters, investigations and litigation. Fred has successfully defended a mass seizure of a major device manufacturer's products worth tens of millions of dollars. He also has been successful in establishing new case law potentially advantageous to claimants in FDA seizure actions. He is former chief of the civil division of the U.S. Attorney's Office for the Northern District of Illinois. While at the Justice Department, he twice received the FDA Commissioner's Special Citation for outstanding contributions in the field of food and drug law enforcement.

Cathy L. Burgess is a counsel in the Health Care Group at the law firm of Crowell & Moring. She advises clients on FDA regulatory matters affecting prescription and OTC drugs, biologics, medical devices and cosmetics. Her practice primarily focuses on compliance, especially related to good manufacturing practices and quality systems. Cathy advises clients on compliance programs, adequacy of SOPs, investigation reports, inspection management, responding to Form 483s, warning letters and recalls. She also conducts internal investigations and special audits related to FDA compliance. Prior to joining the firm, Cathy was associate general counsel for the American Red Cross, where she served as regulatory counsel for the organization. One of her primary responsibilities was providing legal assistance and strategic advice to Red Cross management and the Board of Governors' Audit Committee on matters related to the Red Cross Amended Consent Decree. In 1992, Cathy was the number-two person on the defense team in United States v. Barr Laboratories, Inc., the leading case on current good manufacturing practices for pharmaceutical companies.

Register now!

Date: Nov. 3–21, 2008
Location: Your office or conference room (no need to travel!)
Time: Anytime

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