Full course description
LIVE SESSION: Thursday, November 11, 2021 @9:00am - 10:00am, Zoom
REd Synchronous classes are taught by subject matter experts, and provide both fundamental and advanced skills training in flipped classroom format. These classes are offered live (currently, via Zoom), wherein participants will attend and participate in the 1-hour live lecture/presentation. Participants will be required to work pre-class and post-class activities outside the classroom. These activities can include: readings, videos, etc.
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.
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
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.