2012 FDA Regulatory 101 Course

2012 FDA Regulatory 101 Course
Wednesday, May 23, 2012

CLE Credits Have Been Requested

Presented by a host of Indiana
Medical Device Manufacturing Sector Experts

4 Sponsorships Available
(Sponsorship includes promotions, signage at the event as well as a shared table for materials distribution.
Sign up at the bottom of the Registration Form)

Program Agenda

8:30-9:00 am	Registration / Continental Breakfast / Networking
9:00-9:15	Welcome	Ralph Hall, Counsel, Faegre Baker Daniels
9:15-10:00	Clinical Trials and IDEs 21 CFR 50, 54, 812 Roles and responsibilities FDA submission process Informed consents, IRBs, etc. European Issues	Keli Hankee, Manager, Clinical Affairs, Biomet, Inc.
10-00-10:15	Break
10:15-11:15	Submissions PMA requirements Submission contents Process and issues 510(k) requirements Process and requirements 513(g)	Russell Gray, Sr. Regulatory Consultant The Anson Group
11:15-11:45	Combination Products	Suzanne O’Shea, Partner Faegre Baker Daniels
11:45-12:15	Complaint Handling/Corrections and Removals   Part 806, Part 7 Part 803	Dale Miller, Manager, Regulatory Affairs Zimmer, Inc.
12:15-1:15	Lunch and Networking
1:15-2:15	QSR Overview 820 Design controls Management responsibility Process controls Adverse Event Reporting Other QSR topics	Chris Kilander Regulatory Affairs Manager Cook, Inc.
2:15	Break
2:30-3:15	Advertising and Promotional Controls	Danelle Miller, Global Regulatory Counsel Roche Diagnostics
3:15-4:00	Enforcement / Wrap Up   Administrative, civil and criminal Other Provisions (qui tam, 1001, 371)	Ralph Hall, Counsel Faegre Baker Daniels

Register Online Now!

Registration Only:  8:30 am
Program: 9:00 – 4:00 pm
Location:  Montage Catering Facility, 8580 Allison Pointe Blvd., Indianapolis, IN 46250

Members: $195 per person 
(Member discounts apply when registering more than 4 attendees at the same time)

Non-Members: $275 per person

For more information or to join the IMDMC, please contact Blake Jeffery at IMDMCoffice@ameritech.net.