COURSE ID 2923

FDA Inspection Essentials

Key Dos and Don'ts

AVAILABLE ON-DEMAND
Duration: 90 Minutes
Course Instructor

Danielle DeLucy, M.S.

Price
$ 295
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 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:

  • Explain Pre-planning and preparation activities
  • Outline What to do when the investigator arrives
  • Summarize What documents to have ready and on hand
  • Develop Assignments and responsibilities for the inspection
  • Translate Inspection Dos and Don’ts
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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:

  • Quality Control
  • Manufacturing
  • Senior Management
  • Regulatory Affairs
  • Quality Assurance

Managers and supervisors of this personnel will also benefit from this training by learning about the challenges faced by them.

Course Instructor

Danielle DeLucy, M.S.

Owner, ASA Training & Quality Consulting LLC

Danielle DeLucy, M.S.’s Courses

Accreditation

Team Training

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.

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