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FSMA Training for Preventive Controls Qualified Individual

Preventive Controls Training (PCQI) for Human Foods CFR 21 Part 117

Preventive Controls Training for Human Foods will earn you your certificate to be a Preventive Controls Qualified Individual (PCQI) as required by the FDA. It is a 20-hour offered through MEIRxRS’s Rx Research Services Foundation in addition to the Port of Los Angeles and the National Oceanic and Atmospheric Administration. Attendees of the class will earn a certification to become the Qualified Individual for the United States Food & Drug Administration (FDA) regulation on Preventive Controls for Human Foods.The Preventive Controls training for PCQI will be held at NOAA in collaboration from the Port of LA

WHEN Wednesday, February 22nd, 2017 at 7:30 AM – Friday, February 24, 2017 at 1:00 PM (PDT)

WHERE: NOAA, 501 W Ocean Blvd, Room 3470, Long Beach, CA 90802- View Map

Earn a Certificate of Training from Food Safety Preventive Controls Alliance

Tickets

Class Schedule

Price includes the Preventive Controls handbook, certificate from FDA, lunch and snacks.

Attendees must be present for all 20-hours of class.

  • Wednesday February 22, 2017: 7:30am-5pm
  • Thursday, February 23, 2017:  7:30am-5pm
  • Friday, February 24, 2017:  7:30am-1pm

Materials covered in FSMA Preventive Controls

  • Food Safety Plan & Hazard Analysis Part 1
  • Hazard Analysis Part 2 & Process Controls
  • Allergen Controls & Sanitation Controls
  • Verification and Validation & Record Keeping Procedures
  • Supply Chain Controls & Recall Plan & FDA Regulation CFR 21 Part 117

Take advantage of this low price & finish training early. Avoid getting into compliance too late. 

Why you should attend?

Food & beverage facilities covered under FSMA must establish and implement a food safety system that includes analysis of Hazards and risk-based preventative controls.  The rule sets the requirements for a written Food Safety Plan that includes the body of knowledge of this class set by the Food Safety Preventive Controls Alliance. This training allows you to be recognized as the Qualified Individual, qualified to write the Food Safety Plan and be a reviewer for the all documentation needed by FDA.

The CFR 21 Part 117 regulation will apply for the large businesses (with 500 employees or more) starting September 19, 2016. The rest will need the Food Safety plan starting September 19, 2017, while very small business with less than one million in sales that need a plan by September 19, 2018. FDA or the CA Department of Public Health Food and Drug Branch will be inspecting your firm for your Food Safety Plan and records after these dates.

Documentation for food & beverage facilities

In the past only Seafood HACCP, Fresh Juice HACCP and Meat and Poultry Firms needed any regulatory documentation for compliance with FDA or USDA.  As a result of the FSMA regulations, there are a greater number of companies that qualify. All food products are required to have a Hazard Analysis. Through the results of the Hazard Analysis, if any preventive controls for food safety hazards (Biological, Chemical and Physical hazards) are needed, a Food Safety Plan will be required.

Who Should Attend?

  • Quality Assurance Managers
  • Regulatory and Compliance Managers
  • Microbiologists
  • Food Consultants
  • Business Owners

What Do You Want To Do Next?

  1. Learn about Port of Los Angeles and their Trade Connect for Imports and Exports
  2. Learn about NOAA’s Seafood Certification Program for Imports and Exports

 

Trainer: Masaaki (Mas) Hori

Mas Hori, Preventive Controls Training Instructor

Mas Hori, worked for the California Department of Preventive Health Services, Food and Drug Branch, in the Southern California area for 26.5 years, as a Food and Drug Investigator, Senior Food and Drug Investigator, Supervising Food and Drug Investigator. He has experience in inspecting food products (including low acid food processing and HACCP systems), pharmaceutical products, medical device products, cosmetic products, and the bottled water industry. Prior to joining the California Food and Drug Branch, he worked for the Los Angeles County Health Department, as an Environmental Specialist, inspecting restaurants and markets in Los Angeles.

Since 1996, he has trained over 2000 individuals in HACCP (through the AFDO Seafood Alliance HACCP Training Course and FIBR (Food Industry Business Roundtable) HACCP and GMPs Courses), which is required by federal laws to be applied in wholesale seafood operations. He presently holds a certification for HACCP with ASQ, as a CHA (Certified HACCP Auditor), which standardizes the auditor for auditing HACCP systems for foods.

He is presently working for food and seafood firms in Southern California as their HACCP/ Sanitation/ GMP Consultant.

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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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2016 QLN FSMA Free Half Day Workshop

fsmaworkshop

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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April 8, 2016 QLN University Lecture Series Day with FDA

 

scientist

Free Workshop

In an effort to ensure full transparency with the medical product and dietary supplement industries, the FDA Los Angeles District Office is hosting a Regulatory Policy Lecture Series on how FDA goes about improving product, processes, and service quality through the use of quality tools. During cGMP investigations and through import inspections, FDA has noted several areas where industry could improve product quality. We will share our observations with future regulatory policy professionals and graduate students from local regulatory policy graduate programs. The audience for these lectures includes graduate program students from USC, UCI, Tech Graduate Institute, Chapman University and Cal Poly Pomona. Many of these students are pursuing careers with FDA as employees or quality interns. These workshops will include presentations by FDA quality interns and FDA subject matter experts discussing our current challenges with product quality and use of quality tools to address these quality issues.  For more information, download our booklet.

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Quality Leaders is sponsored by MEIRxRS’s