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Inspection Preparation Training for Drugmakers

Inspection Preparation Training for Drugmakers

December 2013

Managing and leading people through an FDA inspection is a combination of art and science. And no one knows this better than Fred Branding. He has shepherded firms just like yours through hundreds of inspections.

Now he can lead you through the process of building your own inspection preparation plan so you’ll be ready the next time the FDA comes calling.

Spend 2 1/2 hours with Fred and you’ll learn:

  • How FDA investigators prepare when they get the assignment to inspect your company
  • What resources they review about your operations before they set foot on your property
  • What training documents and regulations they must follow as part of the inspection
  • How they craft 483 observations if they find problems

Take a look at Fred in action … 

You’ll walk away knowing:

  • How to develop inspection planning SOPs
  • How to answer investigators’ questions fully — but not too fully
  • What never to say to an FDA investigator
  • How to discuss investigators’ observations — without arguing
  • Making corrections during the inspection that satisfy the investigator
  • And everything else you need to pass your next inspection

Bonus Resources

Inspection Preparation Training for Drugmakers also includes these valuable resources:

  • Guide to preparing your subject matter experts for inspection
  • FDAnews special report: How the FDA Trains and Prepares Investigators
  • FDA Guidance, “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection”
  • Sample FDA Forms 482: Notice of Inspection; and 483: Inspectional Observations
  • Printable presentation slides in note-taking format
Frederick Branding, RPh, JD, is a principal attorney with the Washington, DC law firm of OFW Law and resides in Chicago, IL. He is a registered pharmacist with extensive experience in pharmaceutical, food, drug, medical device, and cosmetic regulatory compliance and enforcement issues, including assisting medical products manufacturers in responding to government inspections, warning letters, investigations and litigation. Representation includes seizures, injunctions and prosecutions, as well as private litigation between businesses. Prior to joining OFW Law, Mr. Branding was in private law practice, served as an assistant U.S. attorney and Chief of the Civil Division for the Northern District of Illinois; and Chief of the Psychotropic Drugs Unit of the U.N. International Narcotics Control Board in Vienna, Austria. As an assistant U.S. attorney, he twice received the FDA Commissioner’s Special Citation for outstanding contributions in the field of food and drug law enforcement.

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