Manage Your FDA Inspection Before It Happens
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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.
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.
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.
Topic Background
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.
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.
Instructor Profile:
Casper E Uldriks
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.
Bar Admissions: Massachusetts, 1986 and District of Columbia, 2011
Education: Suffolk University Law School, Boston, Massachusetts, 1986.
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| Purchase Options | Live Access, Recorded Access, Training CD/DVD, USB Flash Drive, Live+Recorded Access, Live Access+CD/DVD, Live Access+USB Flash Drive |
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