How to Manage and Prepare for a Pre-Approval Inspections (PAI)

Part of the GMP Laboratory Control Professional Certification Program

Duration: 90 Minutes
Course Instructor

Danielle DeLucy, M.S.

$ 195
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

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 training, 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 proper preparation minimizes stress and disorder during the inspections.

Upon completion of this course, you will be able to:

  • Describe Pre‐planning and preparation activities
  • Explain what to do when the investigator arrives
  • Interpret the Pre‐Approval Inspection Compliance Program 7346.832
  • Prepare and have ready the necessary documents needed for inspection
  • Develop assignments and responsibilities for the inspection
  • List inspection Do’s and Don’ts

This training is one part of the 10-course series required for the GMP Laboratory Control Professional Certification Program. Attend this course as part of the certification process or as a stand-along course for personal career advancement and training.

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This course is intended for professionals in the pharmaceutical industry who are charged with Pre-approval inspection readiness. Personnel working in Quality Control, Manufacturing, Regulatory Affairs and Quality Assurance along with their management and supervisory teams will benefit greatly from this training.

Course Instructor


Danielle DeLucy, M.S.

Owner, ASA Training & Quality Consulting LLC

Danielle DeLucy, M.S.’s Courses
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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.

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