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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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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2016 QLN FSMA Free Half Day Workshop


September 15, 2016. This is the second lecture, part of a quarterly Lecture Series where FDA and Industry come together to provide regulatory guidance and Good Manufacturing Practice topics and case studies. This workshop will include presentations by the FDA and Food Industry subject matter experts discussing the current challenges related to product quality and food safety. The primary goal will be to explore methods to resolve these case studies. Registration is limited to FDA employees, Local Food, Ingredient, and Food Supplier Professionals. This facility can only accommodate 85 people.

You must register by September 15th to attend this event. No walk-ins will be allowed due to security requirements at this facility. (Registration Link)

Who Should Attend

Two representatives from each company are highly suggested to attend the FSMA Compliance Workshop 2016: (1) CEO, CFO, or VP of Finance and (2) Head of Quality. This is recommended to improve the support of management in the adoption of new practices. Companies with both representatives get first priority in attending this limited space workshop.

FSMA Compliance Workshop 2016 Agenda

Date: September 15, 2016. Hosted by: LA District FDA

7:00am Registration, Breakfast and Networking

7:45am – 12:30pm

  • Welcome and Introductions.
  • Presentations.
  • Case Study: Jill Golden- (Past SCIFT Chair) Panel Moderator: Participate in real life case study. Discussion will be around about causes, effects and COSTS of non-compliance
    • Supplier Risk Management
    • Supplier Controls
    • Supplier Audits
    • Supplier Verification
    • Supply Chain

Breakfast and refreshments are sponsored by the American Society for Quality (ASQ) Food, Drug & Cosmetic Division, the Quality Leaders Network (QLN) Food Group, RxRS Apprenticeship Program.

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GenomeTrakr: Transforming Food Safety

pathogensJune 27, 2016

FDA has posted a new video about the cutting-edge work of the GenomeTrakr network. The network, consisting of laboratories with whole genome sequencing capabilities, was established to facilitate the sharing of pathogen sequence data between public health agencies, academia, and the food industry, with the goal of preventing large-scale foodborne illness outbreaks.

Whole genome sequencing lets scientists look at the DNA fingerprint of pathogens, bacteria that cause disease. The FDA is increasingly using this technology to more rapidly identify foodborne pathogens and trace them to their source with unprecedented detail and clarity.

Contributing laboratories upload a pathogen’s genetic sequence, as well as information about where the pathogen was gathered, into the publicly accessible GenomeTrakr database. The information can then be used to speed outbreak investigations and to inform foodborne illness prevention strategies in food facilities and on farms.

To see this and other videos on this technology, visit the GenomeTrakr Video Library.

For More Information

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