Complete Guide To FDA Inspection Readiness

You’ve received a communication from the Food and Drug Administration (FDA) regarding an upcoming inspection of your organization, what’s next? An announcement of an FDA inspection can create anxiety, but if the steps and expectations are known, the inspection announcement will be less stressful. In fact, an FDA inspection will provide assurance of study integrity.

Although some inspections may come at a critical time in your clinical research journey, they are meant to protect the rights, safety, and welfare of human research subjects; to verify the accuracy and reliability of clinical trial data submitted to the FDA; and to assess compliance with FDA’s regulations governing the conduct of the clinical trial. Inspections can happen for multiple reasons, including a new drug application, complaint, safety issue, or just a routine inspection. The FDA’s regulations are meant to govern the conduct of a clinical trial, including regulations for investigators, informed consent, and ethical review.

This eBook is designed to help you prepare for an upcoming FDA inspection, outlining what to expect during the investigation, and strategies to employ as the investigation process comes to a close