Training Program Title
What You Should Know Before the FDA Arrives
CTSA Hub Administered
Please contact SOCRA by emailing firstname.lastname@example.org or by calling 215-822-8644.
Training Program Description
This online course is intended to provide access to training and continuing education that will promote quality clinical research, protect the welfare of research participants and improve global health. This Course will discuss the steps involved in an FDA inspection and will address best practices in responding to FDA questions. The faculty will discuss what the FDA is instructed to look for when conducting an inspection and review recommendations regarding what to do after the inspection. The FDA's Compliance Program Guidance Manuals will be explained.
This is a 60 minute internet media player video of a voice over slide show.
A quiz concluding the presentation will summarize the topic and evaluate your understanding of the material.
Digital Commons Disciplines
Medicine and Health Sciences
Cost to Access
Clinical Trials Operations; Study and Site Management
At the completion of the webinar, participants should be able to:
- Discuss the steps of an FDA audit.
- Discuss how to respond to FDA questions
- Have an understanding of the FDA's Compliance Program Manuals
- Understand what the FDA auditor is looking for.
- Discuss how to review recommendations from the FDA after an Audit.
Clinical Research Professionals (other than PI)