Midwest FDC Conference: American Society for Quality – Food, Drug and Cosmetic Division

“Riding the Wave of Change”


  October 22, 2014


NIU Hoffman Estates
5555 Trillium Boulevard
Hoffman Estates, IL 60192

(Google Map link here)


Register at:  https://www.eventbrite.com/e/riding-the-wave-of-change-tickets-11396965631

Early Registration Ends September 15, 2014

Event Details:

How do we address change? Growth in technology, accessibility of information, and globalization presents challenges to management in the regulated industries. Join us in this conference to learn about the impact of change on quality, safety and effectiveness risk management.

Speakers for this conference will provide practical approaches with respect to managing change.

7:30 am  Registration and Continental Breakfast

8:00 am  Welcome and Introductions

8:10 am  State of the Chicago FDA District, Scott MacIntire, Chicago District FDA

8:55 am  The Irony of Economics, Ethnicity, & Ethics in Successful Management of Type 2 Diabetes, Sharon Mayer, Evanston Hospital

9:40 am  Ongoing Changes in the EU Medical Device and IVD Regulations, Phillipe Auclaire, Abbott Laboratories

10:25 am  Break

10:45 am  Proactive versus Reactive Change: A Case for Thinking Preventively, Peter Shearstone, Sysmex America, Inc.

11:30 am  Panel Discussion

12:00 pm  Lunch

12:45 pm  Mini presentations

1:15 pm  Records in the FSMA Age, James Loseke, Sargento Foods, Inc.

2:00 pm  Merging a QMS and Relationship Management Approach to Supplier Quality, Ed Cook, Hospira

2:45 pm  Break

3:05 pm  The Impact of Change on Manufacturing, Russel Riley, Chicago District FDA

4:00 pm  Panel Discussion

4:30 pm  Conference Concludes