Preparing for an FDA Preapproval Inspection

Held May 26, 2011

An FDA preapproval inspection can be an intimidating prospect for pharmaceutical or medical device manufacturers.

They’re no fun to undergo, but possible to pass with the proper preparation.

Everything rides on your preapproval inspection.

But investigators keep taking new angles on everything from material flow and CAPA to stability data. Plus, the FDA is bringing along CDER inspectors — and others — who ask very different questions than the field inspectors.

Don’t let Form 483 observations slap you with last-minute costs, delays and negative publicity.

How can you be sure your sites are thoroughly prepared for these inspections?

Join Frederick Branding and Cathy Burgess for this 90-minute webinar and discover how to prepare for and manage these inspections to avoid misunderstandings, prevent delays in the approval process and eliminate unnecessary costs.

Sign up your entire team to discover:

  • Why you need to ensure a successful inspection
  • Guidance on inspection activities — from drug development to QA controls to document reviews
  • The benefits of a risk-based approach to inspections and what it entails
  • How to prepare for an inspection and what documents are needed
  • How to best handle document requests to avoid problems
  • The best ways to manage an FDA inspection, including key Do’s and Don'ts

Preparing for an FDA Preapproval Inspection is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you work at the office or telecommute from your office at home.

Of course, Mr. Branding and Ms. Burgess will be on hand to answer all of your questions. Simply submit them via email, and you’ll have answers by the time the session ends.

Key people throughout your company 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.

Register now to get the tools you need to turn burdensome inspections into opportunities to fine-tune a well-developed quality assurance system.

This webinar is a must for professionals working in a cGMP environment and those responsible for FDA inspections, including:

  • Pharmaceutical and cGMP auditors
  • Managers
  • Compliance personnel
  • Quality assurance personnel
  • Regulatory affairs professionals

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

Frederick H. Branding, RPh, JD, is a Principal Attorney with the Washington, DC, law firm of Olsson, Frank, Weeda, Terman, Bode and Matz P.C. He is a registered pharmacist with extensive experience in pharmaceutical, food, drug, medical 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.

He also served as a former Chief of the Civil Division of the United States Attorney’s Office for the Northern District of Illinois and Chief of the Psychotropic Drugs Unit of the United Nations International Narcotics Control Board in Vienna, Austria. While at the U.S. Department of Justice, Mr. Branding twice received the Food and Drug Administration Commissioner’s Special Citation for outstanding contributions in the field of food and drug law enforcement.

Cathy L. Burgess is partner in the firm's Health Care Group. Her practice focuses on regulatory compliance, product risk management, enforcement and policy matters affecting industries regulated by the FDA.

Ms. Burgess advises clients on a wide range of matters affecting prescription and OTC drugs, biologics, medical devices, foods and cosmetics, and has extensive experience in the area of current good manufacturing practices. She provides regulatory counsel on investigational new drug applications, investigational device exemptions, good clinical practice, human subject protection and matters regarding institutional review boards. She also provides advice on product approval, preapproval inspections, manufacturing, distribution and marketing. She conducts due diligence reviews and provides regulatory advice concerning complex corporate transactions. Ms. Burgess provides advice on legislative matters affecting FDA-regulated entities, assisting in development of legislative strategies, drafting testimony, preparing clients for interviews with committee staff and providing advice on pending legislation.

Register now!