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RED 404 | Preparing for an FDA Inspection: Lessons from the Field

An introduction to clinical trial FDA inspections. This course will cover how to prepare for an FDA inspection, what to expect during the inspection and how to plan for improvement based on the final FDA report.

At the conclusion of this class, you should be able to:

  • Describe the reasons for and purpose of an FDA Inspection
  • Review how to best prepare for an FDA inspection
  • Articulate what to expect during an FDA inspection
  • Discuss how to improve internal practices based on the outcomes of the inspection

Audience: Faculty, Students, and Staff

Duration: Approximately 2 hours

Format: Synchronous (Zoom)

INSTRUCTOR:

Erin Beck

Erin Beck
Clinical Site Monitor
HCI Research Compliance Office
 
Last Updated: 8/5/22