Archive | January, 2017

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


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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FDA Regulatory Policy Process and Current Trends

QLN PDF File Printing File


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

Key Words

FDA Regulatory Process; FDA Trends; Congress Bills; Regulations


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.


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, 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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