Regulatory Affairs
WPI Medical Device Emerging Leader Program
WPI Corporate and Professional Education is partnering with industry professionals to deliver an educational program that promotes cross-functionality among professionals within the medical device industry. This program will give employees the opportunity to work with industry experts from several key areas of the business. They will be able to choose from thirteen modules to determine the most appropriate “track” of five to meet their professional needs. Relevant case studies will be included to demonstrate the benefit and necessity of cross-functionality.
Key points addressed within this session:
1. FDA Overview
2. The 510(k) PreMarket Notification Process
3. Investigational Device Exemptions
4. The PMA Process
5. Reimbursement Strategies
6. FDA Enforcement
7. Advisory Panels
8. Dispute Resolution
9. Corrections and Removals
10. Promotion and Advertising
11. In-Vitro Diagnostics
12. Combination Products
13. Exporting Devices
14. Medical Device Reporting
15. International Regulatory
16. CE Marking
17. Career Development
Other program topics that overlap with main topic are:
- Regulatory Affairs
- Reimbursement
- Product Design
- Risk Management and Post-Market Surveillance
- Marketing in US and International Markets
Instructors
Dan Bracco
Vice President, Regulatory Affairs and Quality Assurance
Cytyc Corporation
Dan Bracco has worked in the Quality, Clinical, and Regulatory arena for 28 years, mainly specializing in medical devices. He started his career in Deknatel, and has worked in various positions in CR Bard and Cytyc Corporation. He currently is on the Board of Directors of MassMedic, is the manufacturer’s representative on the FDA’s Hematology and Pathology Advisory Panel, and is an active member of the American Society for Quality. He is also Regulatory Affairs Certified (RAC) through the Regulatory Affairs Professional Society.
Program Tracks
Participants select one of the following tracks that align with their professional needs. Individual workshop topics are noted under each track. Note that you can customize a track if you prefer. Completion of five workshops will earn you a WPI Medical Device Emerging Leader Certificate.
Dates, Locations, and CRNs
November 5, 2008
Best Western TLC Hotel, Waltham, MA
Waltham, MA 02453
CRN 18192 MDE004
Schedule and Fees
Workshops will be held once a month. Participate each month that your selected workshop is offered.
Time: 8:30 a.m. – 4:30 p.m.
Fee: $795 per workshop *
* Subsequent registrations from the same company, for the same workshop, is $715 per person
For more information or to register, please contact Corporate and Professional Education at +1-508-831-5517, cpe@wpi.edu.
Maintained by webmaster@wpi.eduLast modified: March 11, 2008 10:54:49