Seminar on FDA Inspections - an Inspectional Lifecycle Approach

Boston, MA, September 12, 2015 (Newswire.com) - Event Date : October 22nd - 23rd 2015
Speaker : Barry Sands
Duration: 2 days
Seminar Link: http://bit.ly/1Mgq83P

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

Included are segments on FDA Law, how to prepare for the inspection, how to prepare your subject matter experts (SME’s), how to manage interactions with the FDA and how to respond to an FDA 483/Warning Letter/Injunction/Import Bans. 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?
• Why responses and associated corrective action plans to 483’s
• Steps for responding to 483’s and Warning Letters.

Name : Puneet Jha, Contact No. : +1-609 256 4556

Email ID : [email protected]