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The FDA conducts various types of inspections depending on what the firm is doing. Inspections follow fairly predictable patterns. You can identify what factors are relevant for your inspections and how the FDA will work with them. The goal of the seminar is to help you figure out what is relevant for how FDA looks at you. Establishing a well-reasoned inspectional strategy on the basis of relevant FDA factors, and how an inspection unfolds, you avoid or mitigate unnecessary policies and procedures that are premised on a defensive stance or an ad hoc management style, which is usually so anxiety laden that the firm becomes its own worst enemy.
Why should you attend: You can understand what an FDA investigator's inspectional approach and questions will be before they even show up at your door. If you do not have a pre-inspection strategy and incorporate relevant FDA concerns, you are standing on the edge of regulatory quicksand. Do you know what the FDA will look for in your facility? It's not a secret. Can you figure out what will be inspected and how the inspection will proceed? That is not a secret either.
Many firms use an ad hoc "war room" mentality for managing inspections rather than a pre-established well-planned strategy to guide the firm through an inspection. The managerial option then, is management through high anxiety or management through rational prediction. When an FDA investigator begins their inspection, they can sense the war room anxiety approach or a defensive posture. That is not a good thing. They can sense the firm is fearful of what may happen next rather than sense the firm is forthright and confident about their regulatory profile. You need to discover effective tools to craft a regulatory evolution for the better. There is no reason to rely on a fingers-crossed pre-inspection strategy. You bring yourself out of a failed defensive tact. Hear from an ex-FDA investigator what the FDA looks for so you are not caught off-guard.
Areas Covered in the Session: