FDA Audit Training

This training will help researchers prepare for FDA inspections and ensure they understand FDA requirements for study management. The training will explain the various types of audits their research may be subject to, what to expect, and how to prepare in the event of an inspection. Common inspection findings are also discussed along with appropriate ways to respond to findings and/or questions from the FDA inspector.

Objectives:

• Describe the purpose of FDA inspection of clinical research
• Describe the processes in place to prepare for an FDA site inspection
• Describe investigator responsibilities and conduct during the FDA inspection process
• Describe the approach to responding to verbal and written findings

Credit Offered: PSNA

Registration is required. The Zoom link will be provided upon registration and you will receive an email reminder the day prior to the session.

Registration:

To register in Penn State's Learning Resource Network (LRN):

Click the LRN Registration Link
Click Request.

College of Medicine and Penn State Health: LRN Registration Instructions 

Attempting to log in to the LRN using a browser where you are already logged in to a Penn State Health website or system will result in an error message. Use the following instructions to register:

Open an incognito window in your current browser.

• Chrome: select the Menu (three vertical dots) in the upper right corner and select New Incognito Window.
• Microsoft Edge: select the More Actions menu (three dots) in the upper right and choose New In Private Window.
• Firefox: select the Menu (three vertical lines) in the upper right corner and select New Private Window.

1. Copy the LRN registration link from the Registration Link section above.
2. Paste the link in the incognito browser's address bar.
3. Log in with your Penn State email address (abc123@psu.edu) and password, not your Penn State Health credentials.