Objectives of the Presentation
Why Should you Attend
- 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
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 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 can have a big impact on a firm's budget, public image, customers, employees and stockholders. No one wants the bad news that the FDA investigator puts on a written list of observations, aka the "483." Your 483 is like a report card that your teacher shows to everyone else in the class. What an investigator finds pulls together many different legal, administrative and technical factors that end up showing you and the public where you stand with the FDA. Inspections cover a wide range of products and an equally broad range of establishments, so preparing for and understanding an inspection takes work that is specific to your firm.
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.