Handling an FDA Inspection

This course addresses the roles and responsibilities of personnel during an FDA inspection. Topics in this course include Personnel Conduct, Inspection Types, Process, Records, Photos and Samples, Concluding an Inspection, and Enforcement. After completing this course, learners will be able to identify the basics of handling an FDA Good Manufacturing Practice (GMP) inspection.

After this course learners will be able to recognize the elements of an fda inspection and your role during the inspection. identify how an inspection is conducted and how to conduct yourself when communicating with an fda investigator. identify the impact of an fda 483. recognize the steps to take when responding to it.