Manage Your FDA Inspection Before It Happens

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 the 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.

• 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 their inspection, they can sense the war room anxiety approach or a defensive posture. That is not a good thing because they can sense the idea of whether the firm is being shady or fearful of what may happen next rather than being confident and 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.

• Regulatory Affairs Director
• Executive Management of Operations
• Quality Assurance Manager
• Manufacturing Managers
• Risk Managers for manufacturing and investigational studies

Mr. Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs. He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program.