FDA Inspection: Preparation and Management

$299.00

Description:

This webinar is intended to help you get familiar with FDA inspection process so that it can be prepared and managed in a proactive and effective manner.

This webinar discusses practical, actionable, and sustainable guidance on how to prepare for a sustainable FDA inspection and how to manage the FDA inspection process including Dos and Don’ts before, during and after the inspection.

This webinar will provide great opportunities to become familiar with the FDA inspection process. The speaker will share his new and useful information for you to consider for implementation and to greatly improve your current process

Areas to be Covered:

Applicable Laws and Regulations
FDA Manuals
Inspection Guides
Hosting an FDA Inspection
Field Management Directives
Inspection Types and Categories
Inspection Classification
FDA Forms 482 and 483
Establishment Inspection Reports (EIRs)
What/How to Prepare for and Manage an FDA Inspection
How to Communicate Before, During and After inspection: Dos and Don’ts
Inspection Preparation Procedures
Close Out Meeting
Responding to 483s, If Issued
How to Communicate with Emotional Intelligence
Employee Training
Actual Case Studies
Conclusion

Who will Benefit:

CEOs
VPs
Compliance Officers
Attorneys
Regulatory Affairs
Clinical Affairs
Quality Assurance
R&D
Consultants
Contractors/Subcontractors
Anyone Interested in the FDA inspection Process

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.

$299.00

membership
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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