The new Hotel Lincoln is a window to the most dynamic part of Chicago's North Side, Lincoln Park.
Like the neighborhood, the hotel is historic yet fresh, fun though eccentric and active but relaxed. It's where the energy of urban life meets 1,200 green acres and Lake Michigan.
Why is FDA at my facility, and what do I do during an inspecti...
Sep 26 2013 - Sep 27 2013
8:30 AM - 5:00 PM
Lincoln Park Conservatory
2391 N Stockton Drive
Chicago, IL 60614
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!Learning Objectives:
If you are looking for answer of these questions, you would certainly benefit by attending this seminar: