The U.S. FDA and NCAFDO
present a
Regulatory Medical Device Workshop
Minneapolis Convention Center
Minneapolis, MN
October 19, 2004
Continental Breakfast, Lunch, and Refreshment Breaks included. Workshop participants will receive valuable workshop material and will be granted free admission to the MD&M Convention Trade Show - one of North America's largest medical device conventions.
NCAFDO has partnered with Canon Communications to facilitate registration for this important regulatory workshop. To register, go to the MD&M site at :www.mdm-minneapolis.com
As you proceed with MD&M registration you are offered the selection of "Session 1000" - this is the NCAFDO workshop. You may register for this workshop alone or choose additional options.
7:30-8:00 Continental Breakfast/NCAFDO Check-in
8:00-8:10 Welcoming Remarks
Charles Becoat, Minneapolis District Director
8:10-9:00 Keynote Address - Dr. Daniel G. Schultz, M.D.-
Director/CDRH
(Current Legislation/ MDUFMA Update/Center Update)
9:00-10:00 MDUFMA-Benefits and Challenges to Industry
(Indiana Medical Device Council Rep.)
Nicholas J. Horvath-Guidant Corporation
10:00-10:15 Break
10:15-11:45 Custom Devices (Medical Alley (Minnesota) Rep.)
Robert J. Klepinski, Partner/Klepinski & DuVal
11:45-12:00 Q&A Morning Sessions
12:00-1:00 Lunch
1:00-2:00 Corrections and Removals and their Relationships to Recalls
Casper Uldricks, FDA/CDRH/OC
2:00-3:00 Canadian Quality Systems Requirements
Don Boyer -Acting Director of the Medical Devices Bureau/ Health Canada
3:00-3:15 Break
3:15-3:45 U.S.Quality Systems Regulations: Overview and Insight
3:45-4:15 Current Violation Trends Seen by FDA
Ronda Mecl-FDA/MIN-DO
4:15- 5:00 User Facility Reporting:
A Hospital’s Perspective (Michigan Medical Device Assoc.
Rep.)
Michael Tanner-William Beaumont Hospital
Royal Oak, MI
5:00-5:15 Q&A Afternoon Sessions
Medical Design & Manufacturing (MD&M) Minneapolis - scheduled for October 19-21 at the Minneapolis Convention Center - features the region's most comprehensive conference and exposition dedicated to medical manufacturing. Be sure to register separately for the MD&M Conference seminars.
For more information, including registering online, go to www.mdm-minneapolis.com. Produced and managed by Canon Communications llc, MD&M® Minneapolis is part of the company's worldwide family of trade events. Information about them can be found at www.canontradeshows.com or by calling (310) 445-4200.
