Why is FDA at my facility, and what do I do during an inspection?
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.
Telephone: +1-650-620-3915; Fax: +1-650-963-2556