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RED 404

Preparing for an FDA Inspection: Lessons from the Field


Scheduled Sessions


INSTRUCTORS


Emily Measom, MPH, CCRP
Senior Clinical Site Auditor
Research Compliance Office

Format:

Synchronous

Duration:

About 2 hours

Audience:

Faculty, Students, and Staff

 

 

This is a REd Synchronous (live) class.

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

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.

Last Updated: 11/17/23