Archive | General Interest

2017 Food Industry Events

Food Events 2017

Food Industry events for food industry professionals and practitioners. These events are not provided as an endorsement but rather as information for review.

Seafood Expo, March 19-21, 2017, Boston, MA https://goo.gl/pFJFA6

Food and Nutrition Conference – May 22-24, 2017, Las Vegas, Nevada http://food.conferenceseries.com/

SeaWeb Seafood Summit– June 5-7, 2017 Seattle, WA  http://www.seafoodsummit.org

Food Safety Tech Food Safety Supply Chain Conference, June 5-6, 2017, Rockville Maryland https://goo.gl/km40dB

Ecolab Food Safety Webinars https://goo.gl/RdwDHq

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FDA Regulatory Policy Process and Current Trends

QLN PDF File Printing File

Authors

A presentation by Marlene GARCIA-SWIDER[1], summarized by AMELIA SPINRAD.

Key Words

FDA Regulatory Process; FDA Trends; Congress Bills; Regulations

Abstract

The FDA issues regulations based on bills issued by the US Congress affecting food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs/medications, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal foods, and veterinary products.

Summary

What federal agency is tasked with protecting and promoting the safety and quality of the food and drugs consumed in the United States? That would be the U.S. Food and Drug Administration (FDA), which is part of the United States Department of Health and Human Services. The Agency regulates food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs/medications, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, and veterinary (animal) foods and medications.

So, what does regulation mean? After Congress passes a bill, the bill becomes a law. Then, this bill is given to experts at a federal agency, like the FDA, to create rules/regulations that must be followed. The FDA also releases guidance documents that help people understand and follow these regulations. While rules/regulations must be followed, guidance documents are not official laws—they are only the Agency’s interpretation on how to comply with FDA Law. Good manufacturing practices should also abide with the Federal Code of Regulation (CFRs) which describe how companies can comply with FDA expectations.

Who is involved in the FDA approval process? Governmental stakeholders include federal advisory committees, the Health and Human Services Office of the Inspector General, the Government Accountability Office, special commissions, other groups, and U.S. citizens who can influence regulations. Why are U.S. citizens involved in the process? Well, whenever a regulation/revision is proposed, there is an announcement on the Federal Register. Public comments are allowed for usually 60 days after the proposal. Anyone can comment by going online to www.Regulations.gov, mail the Agency, or setting up an in-person appointment. The FDA takes all comments seriously and these comments can have a huge impact on decision making by the Agency.

What are some current FDA initiatives? The FDA’s focus is on innovation, globalization, food safety, regulatory science, tobacco, transparency, medical countermeasures, and the Sentinel Initiative for transforming how FDA can best ensure public health and serves the American consumer.

New upcoming regulations to look forward to include but are not limited to:

  • the blood initiative,
  • the revocation of general safety tests in the biologics license application,
  • new over-the counter prescriptions regulations,
  • cold and topical antimicrobial regulations,
  • electronic distribution of prescription information,
  • regulations on fixed-dose combination,
  • abbreviated new drug applications,
  • pediatric study plan requirements, and
  • Investigational new drug application annual reporting. p

 

 

[1] Marlene GARCIA-SWIDER. Quality Manager and CSO at FDA. Orange County, California.

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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 http://qualityleaders.org/medical-devices/

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 http://qualityleaders.org/regulatory-policy/

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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

Agenda

 

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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