Course Spotlight: FDA Inspections - What Regulators Expect and How to Prepare

If you work in the medical devices industry, the pharmaceutical industry, or in biologics, FDA inspections are just part of the job. However, as many entry-level professionals soon discover, preparing for, undertaking, and reacting to the results of an FDA inspection are not easy. In this course by CfPIE instructor Kerry Potter, you will learn how to handle this process from start to finish. When you leave, you’ll be able to meet regulator expectations every time and be confident in your ability to handle the entire process.

Who Is This Course For?

This course on FDA inspections is for any professional that is responsible for getting a company ready for an audit, or any professional who must implement changes after an inspection. Every FDA inspection includes a review of company training records, and it frequently pushes for in-person classroom training, rather than online training. So any managers, department directors, regulatory affairs and quality assurance professionals are often the students that benefit the most from both the structure and the information in this in-person course. This is a practical course with hands-on information that is meant to be taken back to your company and put into action immediately.

What Will You Learn in This Course?

This is a two-day course that packs a lot of material into both days. On the first day, you’ll get a brief overview of FDA inspection guidelines and strategies for inspection day. The class will walk through an in-depth FDA inspection process example, and then there will be a mock audit workshop in which you’ll get to experience an FDA inspection first hand. The first day will conclude with information on legal issues and staff training.

On the second day, you’ll get a checklist for FDA inspections that will help you stay calm and collected on the day of the inspection. You’ll learn about the latest developments in the world of auditing, and then you’ll go through a second hands-on workshop focused on preventative and corrective actions for an FDA inspection. The second day also includes a lecture on how internal auditing can help, but why it’s not a substitute for external auditing.

What Other Students Say

This course has been offered at CfPIE many times before, and student reviews are glowing. The small class sizes make it easy for every student to get the knowledge they truly need, and the hands-on workshops drive home the ideas, so you leave with a great working understanding of FDA inspections. The instructor’s expertise in the field is clear, and students report that he is always passionate about answering as many questions as it takes.

This course runs from 9:00 to 5:00 on both days and breakfast and lunch is provided on both days. Read more about CfPIE’s FDA Inspections Course, and register online. If you register at least a month in advance, you’ll get an early bird discount on the course price.