Medical Devices

Medical Devices Best Practices – Workshop & Series

Friday, October 21, 2016. FDA LOS-DO Main Conference Room at 19701 Fairchild Drive, Irvine, CA 92612
  1. Opening Remarks. FDA QLN and LOS-DO Senior Management
  2. It’s Time to Reimagine CAPA. Glenn D. Yeik, President & CEO, Trimedyne, Inc.
  3. Medical Device Injuries: FDA Data Reveals Increasing Risk. Christina Bernstein, Founder and President, BB Medical Surgical
  4. Quality Metrics Tools ensuring Quality PracticesJoseph Humm, Vice President, Sales Operations, Sparta Computer Systems
  5. Making Decisions Defensible. Kelly Black, Statistician and President, Neptune & Company, Inc.
  6. Medical Devices Regulatory Submissions – Best Practices. Niedre Heckman, Senior Manager, Global Regulatory Affairs Shire
  7. 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
  8. Compliance at LOS-DO. Kelly Sheppard, Director, LOS-DO Compliance Branch
  9. 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
  10. Where Do We Go from Here. Dr. Marlène García Swider, Quality Manager, LOS-DO, FDA, Acting QSM for the PA Biologics Program, ORA, FDA

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