Objectives:
Learners will understand how to prepare for and host an FDA inspection, comprehend potential inspection outcomes for investigators, describe key topics assessed in the FDA’s BIMO Guidelines for Site inspections and connect these with examples of evidence the FDA will review, and understand the guideline as a foundation for quality assurance activities.
The approximate time to complete each session and quiz is noted next to each topic.
Upon successful completion of this course, learners will be eligible to receive 2 continuing education contact hours.
