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FSMA: Preventive Controls for Human Food (PCQI Certification)

FDA-recognized Course Curriculum by FSPCA

Our one-of-a-kind 21 CFR 117 training allows the individual to gain a complete understanding of the new requirements and how they apply to your organization. The Food Safety Preventative Controls Alliance (FSPCA) designed this 2.5-day course in collaboration with the FDA. It is the ONLY PCQI course presently recognized by the FDA as meeting the new requirements. Our course is taught by Lead Instructors for the FSPCA who have successfully completed the Lead Instructor curriculum required to be an official instructor. Upon completing the course, you will meet the requirements as a FSPCA Preventive Controls Qualified Individual (PCQI) who can manage a food safety preventive controls program in accordance with the Hazard-Analysis and Preventive Controls Rule of the US Food and Drug Administration (21 CFR 117).

Requirements of the new regulations include distinctive characteristics that differ from HACCP and from GFSI protocols (SQF, BRC, FSSC 22000) in important ways. Many activities required by the final rule must be conducted or overseen by a Preventive Controls Qualified Individual, or PCQI. This person is defined as “…someone that has successfully completed training in the development and application of risk-based preventive controls as defined by FDA…” 21 CFR 117 training materials include a comprehensive manual, slides, explanations of key PCQI terms and concepts, and example model Food Safety Plans and reference material to help you communicate requirements to your staff. Participants receive an official FSPCA PCQI certificate upon completion.

Initially, many industry professionals worried they would need to completely re-write their entire food safety plans to accommodate the new “HARPC” requirements. Attend our class to learn why it is not a good idea to do this, and in fact, why “HARPC” should not appear anywhere on your plan! If you are surprised by this, you owe it to yourself to attend our class and learn why the HARPC acronym fell out of favor, and what you should do instead. 21 CFR 117 training will clear up all the questions surrounding these any many other questions related to HARPC.

Who Must Comply with the Hazard Analysis and Risk-based Preventive Controls Rule?


Facilities required to register with FDA under section 415 of the Food, Drug, & Cosmetic Act must comply if they manufacture process, pack or hold human food. Compliance with this rule becomes mandatory for large firms in September 2016. Smaller firms have some additional time to comply with this rule, but everyone must be compliant before September 2018. 21 CFR 117 training is a vital part of compliance.


As with all D. L. Newslow & Associates, Inc. courses, the attendees are encouraged to bring their company’s HACCP Plans, Preventive Controls, PRPs, and any other food safety programs to review during breakout sessions. They should feel free to ask any specific questions that may relate to their organization and food sector of interest. We value and encourage the discourse that takes place in our classes and recognize the value brought by the trainees. If you don’t want to feel “talked at” or bored for three days straight, come to our class and learn how we are different from the rest!

Who Will Benefit

Quality, Food Safety, and HACCP managers, food safety HACCP team leaders and team members; those responsible for compliance, quality assurance managers, sanitation managers, system implementation associates (i.e. ISO, FSSC, SQF, BRC, IFS, etc.), regulatory managers, and any associates responsible for specific GFSI compliance and FSMA preventive controls. Even experienced food safety managers should take this course.

What You Will Learn

  • An enhanced understanding of the requirements of FSMA Preventive Controls for Human Food and how these requirements apply to your organization and food sector.

  • Criteria used to identify and implement specific preventive controls for your organization.

  • Process for identifying gaps within your operation between a GFSI approved scheme and FSMA requirements, and real-world techniques for addressing them.

  • Practical applications, common challenges, and pitfalls.

  • 21 CFR 117 training requirements, expectations, and record-keeping strategies to ensure complete compliance.

If you are interested in having us present a workshop specifically designed for your organization at your own site, please call us at (407) 290-2754 or contact us below.


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