The purpose of the Regulatory Inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able to communicate how your quality systems assure this state of control.
Many times, the arrival of a Regulatory Investigator is a daunting experience for some. In this course, you will learn how to properly alert key members that an investigator has arrived, the proper protocol for setting up the inspection room and any associated “war” rooms that will support the inspection, and how to manage requests from the investigators in a timely and accurate manner. This preparation minimizes stress and disorder during the inspections.
Upon completion of this course, you will be able to:
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This training is essential background information for anyone who will interact with FDA during an inspection. Learning what to do and what not to do will improve inspection outcomes and this gained knowledge will be particularly beneficial to professionals in the following areas:
Managers and supervisors of this personnel will also benefit from this training by learning about the challenges faced by them.
When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.Learn more
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