Collaboratively hosted by the ASQ Biomedical Division/New England Discussion Group, MassMEDIC and RAPS, this daylong program is designed to give RA, QA and C-level executives a one-day crash course on the pending regulatory issues facing the industry. The agenda will include comprehensive presentations by FDA officials, industry representatives and regulatory experts.

AGENDA
8:00 a.m. Registration / Continental Breakfast / Networking

8:30 a.m. Welcome Tom Sommer, President, MassMEDIC

CDRH Update Bill Maisel, MD, Deputy Center Director for Science and Chief Scientist, CDRH/FDA

9:45 a.m. MedTech Veterans Program Introduction. Mike Grice, COO, MedTech and BioTech Veterans Program (MVP)

10:00 a.m. Networking Break
10:30 a.m. Welcome, David Leo, Biomedical Resource Consultants Past Chair, ASQ Biomedical Division Co-Founder – New England Discussion Group

Update on International Medical Device Regulatory Forum and the Medical Device Single Audit Program. Kimberly Trautman, Associate Director International Affairs, Office of the Center Director, CDRH, FDA

12:00 p.m. Luncheon Break

1:00 p.m. Welcome, Susan K. Hamann, RAC RAPS, Boston Chapter Chair

Current Status of EU’s Medical Device Directive, Jan van Lochem, CEO & Partner, QServe Group

FDA Northeast Region Update, Mutahar S. Shamsi, USPHS, Acting Regional Food & Drug Director, Northeast Region, FDA

3:00 p.m. Program Concludes