Form 483 and Warning Letter Responses View from the Front Lines of the FDA’s New “Get Tough” Enforcement Strategy

Held Sept. 22, 2011

The recent trend of increasing FDA inspections and warning letters is continuing this year, as the agency has already issued 874 letters in fiscal 2011, compared with 673 last year.  From fiscal 2005 to fiscal 2009, the number of warning letters issued per year hovered in the high 400s.

With increased staffing, the agency has doubled the number of establishment inspection reports reviewed, from 215 in 2006 to 416 in 2011.

As heightened inspections — and warnings — become the “new normal,” it’s vital to know what’s triggering citations and what to do if you’re hit with a Form 483. 

In fact, the more you know about how to handle 483s, the more power you have to handle things without facing subsequent warning letters, consent decrees … and even recalls.

Now, FDAnews helps you mount a timely, effective response to keep inspection citations from leading to further costly consequences.

Ready-to-use guidance from an expert on
Form 483 and warning letter responses

To provide expert advice on this critical issue, FDAnews has engaged Gordon B. Richman — EduQuest’s Vice President for Strategic Compliance and Consulting and General Counsel — to help attendees learn how to survive in this tough new climate.

In just 90 minutes, he will provide a strategic overview plus industry trends, case studies and ready-to-use advice, including:

  • Exactly what Commissioner Hamburg means by “get tough” enforcement
  • Industry trends that alert you to what’s triggering warning letters and consent decrees
  • Examples of what companies could have done to avoidmistakes others have made
  • Techniques to respond successfully to Form 483s — in 15 days or less
  • How to evaluate the intent of the observation
  • What the FDA expects to see when reviewing Form 483 and warning letter responses
  • What not to do in responding
  • And more

A flexible fit for your busy schedule

The Form 483 and Warning Letter Responses webinar is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you’re at the office or telecommuting from your office-in-home.

Of course, Mr. Richman will be on hand to answer all of your questions. Simply submit your questions via email, and you’ll have answers by the time the session ends.
Everyone in your organization — from compliance officers and general counsel to quality assurance and risk management specialists — will benefit from taking part in this event. Best of all, everyone can do so at a cost that won’t break the budget. You pay one single low registration fee per facility, regardless of how many participate. So spread the word.

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

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Gordon B. Richman is Vice President, Strategic Compliance Consulting, and General Counsel of EduQuest, drawing on a unique background and more than 20 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, first as Director of Worldwide Quality Strategy in GlaxoSmithKline’s Global Manufacturing and Supply operations, and then as Vice President of Regulatory Compliance at Fisher & Paykel Healthcare and Vice President of Regulatory Affairs at Masimo Corporation.  Previously, in FDA regulatory practice with major law firms in Washington, D.C., he advised and defended pharmaceutical and medical device companies on a broad range of FDA regulatory issues, including both administrative and criminal enforcement matters.  Mr. Richman has a broad base of experience in the complex, cross-functional issues faced by the FDA-regulated industries, including manufacturing and supply, R&D and IT.  He also has extensive experience in developing and providing training on the FDA’s good practice requirements, regulatory compliance and inspection preparedness. 

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