Managing Effective Regulatory Inspections and 483 Responses

Danielle DeLucy, M.S.

Course description

The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if you want an inspection that results in a satisfactory report. Many times, the arrival of a Regulatory Investigator is a daunting experience for some.

In this accredited 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 training, participants will be able to:

• List pre‐planning and preparation activities
• Describe what to do when the investigator arrives
• Discuss the Pre‐Approval Inspection Compliance Program 7346.832
• Prepare the necessary documents to have on hand
• Develop assignments and responsibilities for the inspection
• List important inspection Do’s and Don’ts

This training is part of a 10 course (15 hour) series required for the FDA Inspection Readiness Certification. Attend this training as a step in the certification process or as a stand-alone course for personal career advancement and training.