Full course description
This is a REd Synchronous (live) class.
LIVE SESSION: Tuesday, March 31, 2026 @1:00pm - 2:00pm Mountain Time (US and Canada), Zoom.
Class Description: 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.
Class Objectives: 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
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Instructor:
Morgan Schenk
Senior Compliance Officer
Research Compliance Office
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REd Synchronous classes are taught by subject matter experts and provide both fundamental and advanced skills training in flipped classroom format. To register for upcoming trainings, click here to view our calendar.
Class Duration: Total duration for synchronous classes are approximately 2 hours. Those two (2) hours will be broken down into:
- A live session which will take approximately 1 hour (45-minute presentation and 15-minute Q&A) and;
- Pre and Post-work activities which will take approximately 1 hour, in total.