Who Should Attend
This course is directed toward those who are responsible for research, development, manufacture, marketing, quality, and/or regulatory compliance within the pharmaceutical and medical device industries. The course will benefit individuals whose job functions include operations governed or overseen by FDA regulations including personnel involved in preparing for, participating in and responding to FDA inspections. Managers, including executive management, will benefit by learning what their direct responsibilities and vulnerabilities are as a result of GMP inspections.
Learning Objectives
This program is designed to provide attendees with the tools and knowledge necessary to upgrade their quality system to current GMP levels. In addition to providing the latest FDA expectations for compliance with Drug and Device GMPs, attendees will learn how to prepare, manage and successfully complete an FDA inspection. Upon completion of this two-day course, the participants will gain comprehensive insight into the FDA’s latest expectations when conducting investigations and how to audit effectively for compliance with those expectations in mind.
Course Description
Personnel attending this interactive program will have an opportunity to learn how to prepare for an FDA inspection, what to expect during interaction with FDA officials and how to respond to FDA observations. Additionally this course is a good refresher for all personnel involved in the FDA inspection process and an opportunity to compare your internal audit system against what a leading internal audit expert believes is the best approach to implement. The course is provided in an informal atmosphere and an easily understood format.
The following are examples of some of the issues addressed during the course:
- What your organization can do to prepare for the inspection
- What information can the FDA request during an inspection
- Can a Warning Letter be issued immediately after an FDA inspection
- When can the FDA take action without issuing a Warning Letter
- What does the FDA look for during inspections
- How does the FDA classify a recall
- What are the timeframes for the U.S. DOJ's and FDA's handling of clear criminal fraud cases
- What type of documentation is required and what is the correct format
- What do the FDA's export regulations mean to your firm
- What types of cases does the FDA refer to the DOJ for prosecution
- When can the FDA suspend, deny or withdraw abbreviated new drug applications (ANDAs)
- How to respond to FDA actions
- Under what conditions can the FDA debar companies and individuals
- What to do after the FDA has taken action
View Course Agenda
Past Participants' Comments
"I am planning to go back and tell my company that this course should be required for all Quality Auditors, as well as, people who create/write procedures. This is the most useful course I've ever taken!"
Jen M., Systems Manager, Schering Plough
"The course was very informative and I will be able to implement a lot of this information in our mock audits."
Maria B., Pharmacovigilance Associate, Pfizer
"Great information, presentation and materials. Thank you!"
Christine S., QA/Training Specialist
"I would recommend this course to my colleagues."
David M., Director, Bayer
“Course content was excellent! It provided a fundamental understanding of the regulatory process.”
Tara M., Regulatory & Compliance Supervisor, Wyeth
"In the Relatively short timeframe available & given the subject matter covered, this course was an excellent overview. Hosted by an excellent tutor in a nice setting too."
Hillsley G., Regulatory Affairs Mgr., Micro Medical Ltd.
"Information is very useable in EU. Information not only related to US situations."
Jan-Willem A., Quality Manager, Sanquin D&R
"It is a great course, it has a lot of information that I’ll use in my company. Great Job!"
Carmen N, QA Manager, Martech Medical Products
“The course director was very knowledgeable and approachable. I would definitely take another class from her and recommend her to others.”
Robbin M., QC Manager, Novo Nordisk
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