Seminar on FDA inspections - An Inspectional Lifecycle Approach in Boston

BOSTON - Sept. 11, 2015 - PRLog -- This two-day seminar will prepare firms to better manage an FDA inspection and designing and implementing a corrective action plan if FDA threatens to take punitive action against them.

This course begins with a high level discussion addressing the legal/regulatory basis for an FDA inspections and types of FDA inspections (understand why FDA is there) and the sanctions available to FDA for those companies who choose not to comply with FDA requirements.

It also includes segments on FDA Law, how to prepare for the inspection, how to prepare your subject matter experts, how to manage interactions with the FDA and how to respond to an FDA 483/Warning Letter/Injunction/Import. Case Studies and Templates are included. Pharmaceutical, Medical Device, Human Tissue, and Combination Product are covered.

Learning Objectives:

Which FDA sanctions apply to you, and how to operate in compliance?
What to do when FDA knocks – step by step instructions?
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?


Contact Name: puneet.jha@atlassystems.com Contact No. : +1-609 256 4556