FDA Inspection Essentials
Start Date: 2021-04-28
End Date: 2021-04-29
Time: 10:00 am to 3:00 pm
The inspection management plan should provide for, Response to the arrival of the investigators, Guidance of the inspectors’ activities, Procedure for working with the investigators, and Documentation of the inspection. The management plan or SOP should spell out all of the procedures that you will follow during an investigation. Personnel training is one key variable that should be looked at prior to any inspection. Educate personnel about the inspection process so they can be prepared. Train individuals to interface with FDA investigators. Verify that training has been provided for the personnel on their current job functions, and that supporting records are on file. The goal is to minimize the opportunity for incorrect answers provided to the inspectors, or providing too much information. Have a list of what to do and what not to do when speaking to the inspectors as well.
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