Risk Management & Post-Market Surveillance
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:
-
Device Vigilance
- Monitoring Safety and Efficacy
- Corrective and Preventative Action
- Post-market Flow Studies
- Adverse Event Reporting
- Product Liability
- Continuous Feedback Loop
Other program topics that overlap with main topic:
- Quality Regulations and Assurance
- Regulatory Affairs
- Customer Needs Assessment
- Manufacturing
- Marketing in US and International Markets
- Sales and Management
Instructor
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
December 12, 2008
Best Western TLC Hotel, Waltham, MA
Waltham, MA 02453
CRN 18198 MDE014
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 09:08:31