Manage Your FDA Inspection Before It Happens

Casper Uldriks
Instructor:
Casper Uldriks
Duration:
60 Minutes
Product Id:
500328
Access:
6 months

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Price Details
$189 Recorded
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Overview:

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:

  • 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

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


Speaker Profile
Casper (Cap) Uldriks, through his firm "Encore Insight LLC," brings over 32 years of experience from the FDA. He specialized in the FDA's medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA's domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. Professional credentials: JD - Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology - Boston University with internship through Harvard University.




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