FDA Update – In Conjunction with ASQ – New England Biomedical Discussion Group & RAPS

When: December 4, 2019, 8:00 am - 3:00 pm
Where: Mass. Medical Society, 860 Winter Street, Waltham, MA

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.

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. Preliminary Agenda 7:30 a.m. Registration / Continental Breakfast / Networking 8:30 a.m. Session one: Public Policy Update, Presented by MassMEDIC Topic: The FDA After Gottleib an insider’s perspective: Aaron Josephson, Senior Director ML Strategies and a former senior policy advisor at the Center’s For Devices and Radiological Health discusses how the agency has changed, after the departure of former Commissioner Scott Gottlieb. What can we expect from the agency in 2020 under the new leadership of Norman Sharpless. 10:00 a.m. Networking and Coffee/Snack Break 10:30 a.m. Session two: ASQ Biomedical New England Discussion Group Topic: FDA New England District Office Update: Joseph Matrisciano, Jr., FDA Director, New England District gives an annual update on the district offices priorities. Topic: The Pre-Submission Process (and industry anecdotes): David Rothkopf, President and Lead Principal, MEDICEPT and Scott Blood Principal Quality and Regulatory Consultant, MEDICEPT discuss the Pre-Submission Process 12:00 p.m. Networking Luncheon 1:00 p.m. Session three: RAPS Boston Chapter Topic: An overview of CDRH’s Standards Program: Scott A. Colburn, CAPT, USPHS Director, Standards and Conformity Assessment Program Standards discuses CDRH’s Standards Program [including Guidance on the Appropriate Use of Standards and Declarations of Conformity, and Draft Guidance on the Accreditation Scheme for Conformity Assessment’ (ASCA) 2:30 – 3:00 pm Wrap up / Q&A 3:00 p.m. Conference Adjourns

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