Archive | September, 2016

Medical Devices Upcoming Workshop

Medical Devices Best Practice Workshop


Friday, October 21, 2016

FDA LOS-DO Main Conference Room at

19701 Fairchild Drive, Irvine, CA  92612



7:30 AM.  Registration & BREAKFAST

(Sponsored by USC and BB Medical &Surgical)

7:45 AM. Opening Remarks. FDA QLN and LOS-DO Senior Management

8:00 AM. It’s Time to Reimagine CAPA. Glenn D. Yeik. President & CEO, Trimedyne, Inc.

8:30 AM. Medical Device Injuries: FDA Data Reveals Increasing Risk. Christina Bernstein, Founder and President, BB Medical Surgical + Joseph O’Neill, Senior Associate, Marketing, The Expert Institute

9:00 AM. Quality Metrics Tools ensuring Quality Practices.  Joseph Humm. Vice President, Sales Operations, Sparta Computer Systems

9:30 AM. BREAK

10:00 AM. Making Decisions Defensible. Kelly Black, Statistician and CEO, Neptune Inc.

10:30 AM. Medical Devices Regulatory Submissions – Best Practices. Niedre Heckman, Senior Manager, Global Regulatory Affairs Shire

11:00 AM. Being There, Done That – Life on the Other Side. Tales From the Trails. Past and Present Medical Devices field CSOs now self-employed Medical Device consultants:  Susan Bain, Professor. Keck Graduate Institute, USC + Trudy Papson, President.  Regulatory Consultants Group. LLC +  Kim Walker, Global RA & QA Consultant.  Kim Walker Consulting

11:40 AM. Compliance at LOS-DO. Kelly Sheppard, Director, LOS-DO Compliance Branch

Noon. LUNCH (Sponsored by USC and BB Medical & Surgical)

1:00 PM. Benefit-Risk Guidance and the CDRH strategic Priorities (including Case for Quality). Robin Newman, Director CDRH Office of Compliance, FDA + Ann Ferriter, Director for Division of Analysis and Program Operations, Office of Compliance, Center for Devices and Radiological Health

2:00 PM. Where Do We Go from Here  & Adjournment. Dr. Marlène García Swider, Quality Manager, LOS-DO, FDA. Acting QSM for the ORA Biologics Program, ORA, FDA

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