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Objectives of the Presentation

• How to prepare for an FDA inspection
• Development and content of an SOP for FDA inspection
• Personnel training before inspection
• How to behave during an inspection
• What to show FDA during an inspection
• Proper Post-inspection Follow-up
• Limitations and scope of inspection
• Response to investigation findings
• FDA guidance documents used by their inspectors

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 inspection, he/she can sense the war room anxiety approach or a defensive posture. That is not a good thing. He/She 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.

Instructor Profile:

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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 virtual 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.

Objectives of the Presentation

• FDA’s inspectional programs
• Relevant risk factors for inspection selection
• The FDA’s inspectional procedures
• Your inspectional plan and protocol
• Interacting with the FDA / Human Factors
• What not to do during an inspection

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 inspection, he/she can sense the war room anxiety approach or a defensive posture. That is not a good thing. He/She 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.

Who will Benefit

• Regulatory Affairs Director
• Executive Management of Operations
• Quality Assurance Manager
• Manufacturing Managers
• Risk Managers for Manufacturing and Investigational Studies

FDA inspections are assigned for many different reasons. Safety (risk to health) plays a major role in how FDA selects firms for inspections. Firms can estimate their likely risk status in terms of FDA’s regulatory interest. Once a firm is selected for inspection, how the inspection is conducted becomes a make-or-break situation. Inspections are designed to find problems. They are inherently uncomfortable for the people who host the investigator during the inspection. Predicting what an investigator will do during an inspection becomes helpful in how you manage a difficult situation to avoid a potentially disastrous and costly result.

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