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FDA Inspections
This course provides learners with information about why, when, and how FDA inspections of clinical investigation sites and sponsors occur. Learners will gain a detailed understanding of the FDA’s compliance program guidance manual, the items assessed by FDA inspectors, and best practices to help research teams prepare for and host inspections.

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.

Sessions Included:
    1.     FDA Inspections 101 - (55 minutes)
    2.     FDA Inspections 102 - (55 minutes)

$100.00
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