The United Natural Products Alliance (UNPA) has begun providing onsite Preventive Controls Qualified Individual (PCQI) training for food and dietary supplement companies after the successful completion of a PCQI training session for UNPA member Indena at its corporate headquarters in Milan, Italy.
The PCQI trainings provides exercises specific to food and dietary supplements and dietary ingredients. The Food Safety Preventive Controls Alliance (FSPCA) developed the course, which is the “standardized curriculum” recognized by the U.S. Food and Drug Administration (FDA).
At the end of this training program, participants will:
Receive a PCQI certificate of training
Understand Good Manufacturing Practices and Prerequisite Programs
Conduct hazard analysis and determine preventive controls Implement process, allergen, sanitation and supply-chain preventive controls
Implement verification, validation, recall and recordkeeping requirements
Develop and implement a Food Safety Plan for their production facility.
Who needs to have a PCQI on staff?
A food company, brand holder or contract manufacturer that manufactures, packages, holds or distributes a food product using a Nutrition Facts panel is required to have a PCQI. This includes natural products and functional foods, such as protein shakes and 'power' bars.
Dietary Ingredients (raw material) are classified as a food and therefore, ingredient suppliers are subject to the full requirements. These suppliers include companies providing botanical powders used in dietary supplements, such as echinacea, gingko, and others. Any company distributing a dietary supplement would be expected to qualify their suppliers of these ingredients to ensure they are compliant with the new regulation.
Companies and products using the Supplement Facts panel are required to ensure that all of their ingredient suppliers—including all foreign suppliers—have at least one PCQI on staff. Therefore, it is highly recommended that each finished supplement manufacturer or distributor be fully educated about PCQI so that they can qualify their entire supply chain as required by FSMA to eliminate or prevent hazards from being introduced into the food supply.
UNPA has created an article, “An introduction to PCQI,” as well as a PCQI FAQ, both of which answer key questions about PCQI training.
NOTE: Based on FDA/FSPCA requirements, PCQI training consists of a full 20 hours of intense instruction. During this 2.5-day training, attendees are required to put away their cellphones and computers and fully participate in the entire session.
The agenda for PCQI training
8:30am - 5:00pm
Chapter 1: Introduction to Course
Chapter 2: Food Safety Plan Overview
Chapter 3: Good Manufacturing Practices and Other Prerequisite Programs
Chapter 4: Biological Food Safety Hazards
Chapter 5: Chemical, Physical, and Economically Motivated Food Safety Hazards
Chapter 6: Preliminary Steps in Developing a Food Safety Plan
Chapter 7: Resources for Preparing Food Safety Plans
8:00am - 5:00pm
Chapter 8: Hazard Analysis and Preventive Controls Determination
Chapter 9: Process Preventive Controls
Chapter 10: Food Allergen Preventive Controls
Chapter 11: Sanitation Preventive Controls
Chapter 12: Supply Chain Preventive Controls
8:00am - 12:30pm
Chapter 13: Verification and Validation Procedures
Chapter 14: Record-keeping Procedures
Chapter 15:Recall Plan
Chapter 16: Regulation Overview—GMP and Hazard Analysis and Risk-based Preventative Controls for Human Food
Larisa Pavlick has more than 20 years of combined experience working within the dietary supplement industry, plus nearly eight years as an investigator at the U.S. Food and Drug Administration. Through robust scientific research and collaboration with her mentors, she has assisted in the formulation of products designed to support the negative effects of nutritional deficiencies, stress, aging and more. During her career, Larisa has dedicated herself to helping ensure consumers receive the benefits of safe and ethical vitamins, minerals, botanicals and other dietary supplement products.
Kathy Gombas is currently a member of the Food Safety Preventive Controls Alliance Steering Committee and co-chair for the International Subcommittee working on industry training, outreach, and technical assistance programs for food companies worldwide. Formerly Kathy was the Senior Advisor for FSMA Implementation with the U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition (CFSAN). While at CFSAN, Kathy supported the Agency’s Food Safety Modernization Act (FSMA) implementation efforts including the Preventive Controls Regulator Training and launch of FDA’s FSMA Technical Assistance Network for industry.
Eric Zhang has more than 20 years of experience, working in various food safety related technical and management levels, specializing in HACCP-based food safety management system development and implementation. Eric is a Certified HACCP Auditor by the ASQ. He is a Lead Instructor for the Food Safety Preventive Controls Alliance (FSPCA) as well as for the International HACCP Alliance. Eric has a B.Sc. in Food Engineering from Fuzhou University and a M.Sc. in Food Safety and Quality Assurance from the University of Guelph.
* Larisa Pavlick is UNPA’s lead PCQI instructor. Other instructors will train with Larisa depending on class size.
For more information about UNPA’s onsite PCQI training, please contact Kira Olsen, 801.474.2572.