Effective inspection management starts with understanding what the law permits FDA to do, what the FDA is prohibited from doing, and what is discretionary — that is, up to you — whether to permit the FDA to do or not. Areas open to inspection, records you must provide, facts you must disclose and what the FDA is prohibited from doing, whether or not to permit photography, why the FDA tries to get you to sign an affidavit and whether or not you must do so, access to internal audit reports, etc. are all among the areas you need to think about and cover by policy and procedure.
FDA makes a host of resources available online for you to use to prepare for inspections, but do you know what they are, how to find them and how to use them? Do you know the difference between a Compliance Policy Guidance Manual transmittal (“Compliance Program”) and a Compliance Policy Guide? Do you know which parts of the Investigations Operations Manual are important to you and which are not? How about the Regulatory Procedures Manual — what is it, how is it helpful in inspection management, and how do you use it? Do you know how Preapproval Inspections differ from everyday GMP inspections, and why that matters? How does a Pre-License inspection for a BLA different from a PAI for a small molecule drug? What is in the Staff Manual Guides that might come up during an inspection (and what is that document in the first place)?
Do you really understand what an FDA-483 is? Why does FDA say it is not a final determination of non-compliance? What about this 15 business day period for you to submit a response, is that a legal mandate or something optional, and how do you find out? How should you best manage the exit discussion? What about oral observations that are not on the 483? Are there violations that FDA is actually prohibited from putting on the 483 that might be in a warning letter later on? What makes a response to a 483 a good one or a poor one?
This program will demystify these and many other questions. You’ll learn how to prepare for an inspection, how to encourage the investigator to see you in a state-of-control and how — if the worst happens — to manage a 483 observation and reduce the chance that you will get a warning letter.
