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

When: « Back to Calendar December 9, 2015 @ 8:30 am - 3:30 pm
Where: Massachusetts Medical Society
860 Winter St
Waltham,MA 02451
USA
Cost: $ 150
Categories: MassMEDIC Events

SPONSORS

 

Collaboratively hosted by the ASQ Biomedical Division/New England Discussion GroupMassMEDIC 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

7:30 a.m.

Registration / Continental Breakfast / Networking
 

8:30 a.m.

Congressional Upate: 21st Century Cures – What’s in it for MedTech
Paul T. Kim, Partner, Foley Hoag, LLP

Progress Report: The Medical Device Innovation Consortium
Bill Murray, President & CEO, Medical Device Innovation Consortium 

Trends in FDA MedTech Approvals and Clearances – A Regional Analysis
Debbie Paul, CEO Americas, Evaluate MedTech
 

10:00 a.m.

Networking Break 
 

10:30 a.m.

UDI – The regulation and the problems the companies have encountered
Greg Bylo, Vice President, Healthcare, GS1 US

Update from FDA Local District Office
Joseph Matrisciano Jr., Acting District Director, New England District

 

12:00 p.m.

Networking Luncheon
 

1:00 p.m.

Office of Regulatory Affairs (ORA) Program Alignment Update
Mutahar Shamsi
(Immediate Past District Director, FDA New England District)
Specialist Leader | Deloitte Advisory
Regulatory Risk & Compliance, Life Sciences and Healthcare
Deloitte & Touche LLP

FDA’s Case for Quality
Tamara Rosbury, Ph.D.
Acting Case for Quality Program Manager, CDRH Office of Compliance
Medical Device Specialist, FDA New England District Office

The Case for Quality initiative aims to shift the focus from the minimum operational compliance requirements to a higher sustained level of quality, which can provide end users with a better product and greater return on investment in quality for device companies through fewer recalls and adverse events and greater consumer confidence in their products.

 

3:00 p.m.

Conference Adjourns