Full course description
Is your study likely to be audited by FDA? Learn simple things you can do to build audit readiness into your study operations and what important steps to follow once you learn FDA is coming.
By attending this workshop, you will:
- Identify Stanford resources and policy surrounding FDA audits
- Describe what makes a study more likely to be audited by FDA
- Evaluate FDA basic audit-readiness for industry-sponsored or investigator-initiated studies
- Describe the FDA inspection process – before, during and after
- Prepare “vital statistics” for a study and be ready to answer questions during an audit
- Demonstrate increased confidence when communicating with FDA
Course open to all faculty, fellows/residents, staff working on clinical research projects at Stanford.
Date: Wednesday April 9th, 2025
Time: 12:15 - 1:45 pm
Location: Virtual Seminar
Note: This class will be held LIVE on the date and time above. After enrolling, return to the course website to download the course materials and find the zoom information.
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Certificate Program: Elective Class
Core Competency: Clinical Trials Operations