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
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
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
Order Your Copy Today!
DVD — $397
(Add $10 shipping and handling per DVD for DVDs shipped to the US, or $35 per DVD for DVDs shipped elsewhere. VA residents, please add 6 percent sales tax.)
Your risk is zero when you purchase under our money-back guarantee. Not satisfied with the Inspection Preparation Training for Drugmakers DVD? return it within 30 days (in reasonable condition) for a 100 percent refund of your purchase price (less shipping/handling).