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.
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?
Use coupon code NB5SQH8N and get 10% off on registration.