2011 FDA Regulatory 101 Course – Wednesday, May 18, 2011

CLE Credits 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

8:00-8:30 am
Registration / Continental Breakfast / Networking

8:30-9:00
Welcome/Overview
Ralph Hall, Counsel,
Baker & Daniels

9:00-9:45
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.

9:45-10-00
Break

10:00-11:00
Submissions
PMA requirements
Submission contents
Process and issues
510(k) requirements
Process and requirements
513(g)

Colleen Hittle, Managing Partner
The Anson Group

11:00-11:30
Combination Products
Suzanne O’Shea, Partner
Baker & Daniels

11:30-12:00
Complaint Handling/Adverse Event Reporting
Laura Lyons, VP, Clinical, Quality & Regulatory Affairs,
SonarMed

12:00-1:15
Lunch and Networking

1:15-1:45
Corrections and Removals
806, Part 7
Chris Kilander, Regulatory Manager/ Corporate Compliance Administrator
Cook Urological, Inc

1:45-2:30
QSR Overview
820
Design controls
Mgmt. responsibility
Process controls
Other QSR topics

Richeal Cline, Quality Director,
Roche Diagnostics (invited)

2:30-3:15
Advertising and Promotional Controls
Danelle Miller, Regulatory Counsel
Roche Diagnostics

3:15-3:30
Break

3:30-4:00
Enforcement
Admin., civil & criminal
Other Provisions (qui tam, 1001, 371)

Ralph Hall, Counsel
Baker & Daniels

4:00-4:30
Emerging Trends Q&A
Panel of Prior Speakers

Register Online Now!

Registration Only: 8:00 am
Program: 8:30 – 4:30 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.

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s


%d bloggers like this: