2012 FDA Regulatory 101 Course Wednesday, May 23, 2012
Approved for 5.3 Hours of CLE Credit
Presented by a host of Indiana Medical Device Manufacturing Sector Experts
Sponsored by Samco & Associates, Inc.
2 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! Use your username and password to expedite registration by prefilling the registration form!
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.
