FDA Inspections : Get Ready Now or Get Cited Later

When FDA shows up at your front door to announce an inspection, what do you think is going to happen? More importantly, what are you going do?

An ex-FDA investigator will conduct this webinar to share an “insider’s” perspective about inspections. You may find answers to the question, “What is he thinking?” when the investigator starts digging through the complaint files or starts reading memos on lunch room bulletin board.

Firms with an established FDA inspection protocol typically understand what happens during an inspection and why an inspection should be managed carefully. Many firms do not understand FDA inspections or may not have given them serious thought. That type of firm seemingly plans in a panic.

How you manage an FDA inspection and the outcome of an inspection can have a material impact on the firm’s business, if not survival. The core direction of FDA inspections is to determine a firm’s level of compliance with FDA requirements and collect evidence to use against the firm for failing to comply with any regulatory requirement. The negative inspectional outcome can be costly in terms of money, lost business, consent decrees and the prosecution of the firm’s executives. Every FDA inspection concludes with a warning to that effect. How you manage an inspection can significantly affect the outcome. Prior knowledge about what happens during an inspection can serve you well and help you avoid trouble with FDA.

Areas Covered in the Session :
FDA’s overall inspectional program
FDA inspection preparation
FDA regulatory Compliance Programs
Investigations Operations Manual
Inspectional techniques

Who Will Benefit:
Note: All of the following areas are subject to FDA inspectional coverage
Senior Executives who are ultimately responsible for the firm
In-house legal counsel
Senior managers for Operations
Senior managers for Marketing
Regulatory Affairs Managers
Quality Assurance Managers
Manufacturing and Design Managers
Risk managers
FDA consultants

Casper E. Uldriks

Casper (Cap) Uldriks 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 as 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. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap is the President of Encore Insight LLC, a consulting and training service for FDA law and operations.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance