Archive | Newsletter

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

Sharing is Caring:
Continue Reading

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.

Sharing is Caring:
Continue Reading

We are now Quality Leaders

easyfsma to qln2

We are evolving, now we are Quality Leaders. The ASQ FDC Division is the proud sponsor of This website, “Quality Leaders,” is maintained in association with the Quality Leaders Network (QLN) group. Its purpose is to provide a space that allows academia, industry, and FDA to exchange information, to network, to collaborate, and to communicate topics of common interest. Quality Leaders initiated activities as created to assist small to mid-size companies to comply with the Food Safety Modernization Act signed by President Obama. Recently the website expanded to support other QLN subgroups. During the 2016 summer, Quality Leaders will add a periodic publication that will offer study summaries, key points, and other informative and educational material related to the FDA’s scope, including but not limited to public health issues, regulations, and their programs and activities. This enhancement will be led by the University of Southern California’s Regulatory Science Program.

Sharing is Caring:
Continue Reading

Quality Leaders is sponsored by MEIRxRS’s