This two day course will prepare firms for a quick, productive, and efficient FDA inspection. Included are segments on FDA Law, how to prepare for the inspection, how to prepare your subject matter experts (SME’s) to respond properly, and how to respond to an FDA 483 or Warning Letter. Case Studies and Templates are included.
This course begins with a high level discussion about why FDA conducts inspections and the sanctions available to FDA for those companies who choose not to comply with FDA requirements. Next, we cover what to expect during the inspection, including how to communicate with the investigators, run your front and back rooms, and present documents and records. We cover do’s and don’ts, choosing your core inspection team, facilitators, Subject Matter Experts (SME’s), runners and scribes. We provide tips for Executive Management/CEO’s, Production area staff, Reception Area staff and what each group needs to know during an inspection. The session includes real life inspection scenarios/case studies. Participants are given real life FDA inspection scenarios and are asked to discuss how they would handle each situation. Feedback is given on how to best handle each situation and scenario. This is one of our most popular training sessions!
If you are looking for answer of these questions, you would certainly benefit by attending this seminar:
- Which FDA sanctions apply to you, and how to operate in compliance with FDA requirements.
- What to do when FDA knocks – step by step instructions to handle inspections.
- How to handle day by day inspection scenarios?
- What is a front room and back room? Do you need one?
- Runners and Scribes? What do they do?
- Are your SME’s the right people, and are they ready/right for the job?
- Why responses to 483’s and Warning Letters are critical?
- Steps for responding to 483’s and Warning Letters.
Who will Benefit: