North Jersey Section 0304 Meetings
2008-2009 General Section Meeting Calendar

General Section Meetings are held on the 3rd Wednesday of each month at the La Quinta on Rte. 46 in Fairfield unless other plans are made. Meetings begin at 6:00 PM with dinner at 6:30 PM and the program at 7:30 PM.

March 18, 2009 Meeting

GMPs for the 21st Century
A Risk Based Approach
Steven Ostrove, Ph.D.

What changes have we seen since the beginning of the 21st century? What changes in the GMPs can we expect in the coming years? How can we implement these changes?

These are all questions that have been asked, and not necessarily answered. We are still early in the 21st century but the FDA has changed direction. The agency is no longer taking a reactive approach to the drug and device industries. They have become proactive. What does this mean and how does it affect us?

This talk will give a brief overview of the changes in the FDA approach and what we mean when we say we are 'taking risks' in drug and device production.

 

Reservations Required by NOON Friday March 13, 2009
Preferred: RSVP via E-mail the Arrangements Chair at martinge@umdnj.edu.
Please include your membership number and company name in the e-mail.
2nd choice is to call 973-694-4300.