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
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
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.


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