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.