Archive | October, 2016

Two New QLN Pages

2 new QLN pages

QLN continue its expansion. We added 2 new pages,

1. Medical Devices Page

This page contains the following presentations from the Medical Devices Best Practices Workshop held on October 21, 2016

  1. It’s Time to Reimagine CAPA. Glenn D. Yeik, President & CEO, Trimedyne, Inc.
  2. Medical Device Injuries: FDA Data Reveals Increasing Risk. Christina Bernstein, Founder and President, BB Medical Surgical
  3. Quality Metrics Tools ensuring Quality PracticesJoseph Humm, Vice President, Sales Operations, Sparta Computer Systems
  4. Making Decisions Defensible. Kelly Black, Statistician and President, Neptune & Company, Inc.
  5. Medical Devices Regulatory Submissions – Best Practices. Niedre Heckman, Senior Manager, Global Regulatory Affairs Shire

More information at

2. Regulatory Policy

This page’s content is developed by students from the University of Southern California (USC) – Local Regulatory Policy Graduate Program. The new material includes,

  1. Reusing Single Use Devices: Three PerspectivesSpeaker: David Locke, DRSc, Doctoral graduate, USC
  2. FDA Mission and VisionSpeaker: William Martin, PhD, Acting Director for Pacific Region, FDA
  3. How FDA Conducts Import Operations at the US Ports and its role in Consumer ProtectionSpeaker: Dan Solis, Director of Import Operations, Los Angeles District.
  4. FDA Regulatory Policy Process and Current TrendsSpeaker: Marlène García Swider, PhD, Quality System Manager, FDA Los Angeles District

More information at

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