Medical Devices Best Practices – Workshop & Series
Friday, October 21, 2016. FDA LOS-DO Main Conference Room at 19701 Fairchild Drive, Irvine, CA 92612
- Opening Remarks. FDA QLN and LOS-DO Senior Management
- It’s Time to Reimagine CAPA. Glenn D. Yeik, President & CEO, Trimedyne, Inc.
- Medical Device Injuries: FDA Data Reveals Increasing Risk. Christina Bernstein, Founder and President, BB Medical Surgical
- Quality Metrics Tools ensuring Quality Practices. Joseph Humm, Vice President, Sales Operations, Sparta Computer Systems
- Making Decisions Defensible. Kelly Black, Statistician and President, Neptune & Company, Inc.
- Medical Devices Regulatory Submissions – Best Practices. Niedre Heckman, Senior Manager, Global Regulatory Affairs Shire
- Been There; Done That – Past and Present Medical Device Field Observations Panel Discussion.
- Eri Hirumi, Auditor, TUV SUD – Field observations from ISO 13485 audits, harmonizing terminology and definitions with ISO standards, and tips on how to “prove state of the art” to help keep your Technical Files updated
- Kim Walker, Global RA & QA Consultant and SDSU/CSUF Instructor – Field observations from 21 CFR 820 audits, tips on becoming successful regulatory professionals, and Warning Letter case study and related project management skills needed.
- Trudy Papson, President, Regulatory Consultants Group, LLC – Review of publicly available prosecution case studies of non-compliant companies.
- Susan Bain, Professor, Keck Graduate Institute – Field observations of 21 CFR 820 FDA inspections and compliance best practices for new regulatory professionals
- Compliance at LOS-DO. Kelly Sheppard, Director, LOS-DO Compliance Branch
- 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
- Where Do We Go from Here. Dr. Marlène García Swider, Quality Manager, LOS-DO, FDA, Acting QSM for the PA Biologics Program, ORA, FDA