December 5-7
Lehi, Utah
REGISTRATION IS CLOSED.
Lehi, Utah
REGISTRATION IS CLOSED.
Pricing/Registration
UNPA Member & MOU Partners: $895.
Non-Member: $1,095.
This class fulfills the FDA Requirement for a Preventive Controls Qualified Individual (PCQI) under The Food Safety Modernization Act (FSMA).
UNPA Member & MOU Partners: $895.
Non-Member: $1,095.
This class fulfills the FDA Requirement for a Preventive Controls Qualified Individual (PCQI) under The Food Safety Modernization Act (FSMA).
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.
About the course
FSPCA Preventive Controls for Dietary Supplements
This UNPA 2.5-day PCQI training course provides case studies specific to food and supplement production. This course was developed by the Food Safety Preventive Controls Alliance (FSPCA) and is the “standardized curriculum” recognized by the Food and Drug Administration.
Successfully completing this course is one way to meet the requirements for a “preventive controls qualified individual (PCQI).” A PCQI is a professional that can manage a Food Safety Plan at a facility in accordance with FSMA.
The course will be led by Larisa Pavlick, UNPA’s VP of Global Regulatory & Compliance, a former FDA investigator, who is a PCQI and has completed PCQI Lead Instructor training through FSPCA.
The Food Safety Preventive Controls Alliance is a broad-based public-private alliance, consisting of key industry, academic and government stakeholders, whose mission is to support safe food production by developing a nationwide core curriculum, training and outreach programs to assist companies producing human and animal food in complying with the preventive controls regulations that are part of the Food Safety Modernization Act.
At the end of this training program:
This course meets FDA’s PCQI training requirements. Participants will receive official FSPCA Preventive Controls Qualified Individual certificates, issued after attending this training program.
About FSPCA
The Food Safety Preventive Controls Alliance is a broad-based public-private alliance, consisting of key industry, academic and government stakeholders, whose mission is to support safe food production by developing a nationwide core curriculum, training and outreach programs to assist companies producing human and animal food in complying with the preventive controls regulations that are part of the Food Safety Modernization Act.
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.
About the course
FSPCA Preventive Controls for Dietary Supplements
This UNPA 2.5-day PCQI training course provides case studies specific to food and supplement production. This course was developed by the Food Safety Preventive Controls Alliance (FSPCA) and is the “standardized curriculum” recognized by the Food and Drug Administration.
Successfully completing this course is one way to meet the requirements for a “preventive controls qualified individual (PCQI).” A PCQI is a professional that can manage a Food Safety Plan at a facility in accordance with FSMA.
The course will be led by Larisa Pavlick, UNPA’s VP of Global Regulatory & Compliance, a former FDA investigator, who is a PCQI and has completed PCQI Lead Instructor training through FSPCA.
The Food Safety Preventive Controls Alliance is a broad-based public-private alliance, consisting of key industry, academic and government stakeholders, whose mission is to support safe food production by developing a nationwide core curriculum, training and outreach programs to assist companies producing human and animal food in complying with the preventive controls regulations that are part of the Food Safety Modernization Act.
At the end of this training program:
- Participants will receive their PCQI certificate of training
- Understand Good Manufacturing Practices and Prerequisite Programs
- Conduct hazard analysis and determine preventive controls
- Develop and implement a food safety plan for their production facility
- Define process, allergen, sanitation and supply-chain preventive controls
- Implement verification, validation, recall and recordkeeping requirements.
This course meets FDA’s PCQI training requirements. Participants will receive official FSPCA Preventive Controls Qualified Individual certificates, issued after attending this training program.
About FSPCA
The Food Safety Preventive Controls Alliance is a broad-based public-private alliance, consisting of key industry, academic and government stakeholders, whose mission is to support safe food production by developing a nationwide core curriculum, training and outreach programs to assist companies producing human and animal food in complying with the preventive controls regulations that are part of the Food Safety Modernization Act.
Media Sponsor:
Answers to Frequently Asked Questions regarding PCQI, including who must have a PCQI on staff, can be found here.
Read the UNPA article, "Who's your PCQI?" with background and information on FSMA requirements around PCQIs here.
UNPA’s PCQI Qualified Individual Workshop Agenda
Lehi, Utah
December 5-7
Wednesday, December 5
8:00-8:30am Continental breakfast and check in
8:30am - 5:00
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
Thursday, December 6
8:00-8:30am Continental breakfast
8:30am - 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
Friday, December 7
8:00-8:30am Continental breakfast
8:30am - 12:30pm
Chapter 13: Verification and Validation Procedures
Chapter 14: Record-keeping Procedures
Chapter 15: Recall Plan
Chapter 16: Regulation Overview—cGMP and Hazard Analysis and Risk-based Preventative Controls for Human Food
NEW!
1:30 - 3:30pm Optional, no-charge, 2-hour “application session” to help attendees better apply the training learnings to their day-to-day work.
Continental breakfast, lunch and breaks will be provided.
Read the UNPA article, "Who's your PCQI?" with background and information on FSMA requirements around PCQIs here.
UNPA’s PCQI Qualified Individual Workshop Agenda
Lehi, Utah
December 5-7
Wednesday, December 5
8:00-8:30am Continental breakfast and check in
8:30am - 5:00
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
Thursday, December 6
8:00-8:30am Continental breakfast
8:30am - 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
Friday, December 7
8:00-8:30am Continental breakfast
8:30am - 12:30pm
Chapter 13: Verification and Validation Procedures
Chapter 14: Record-keeping Procedures
Chapter 15: Recall Plan
Chapter 16: Regulation Overview—cGMP and Hazard Analysis and Risk-based Preventative Controls for Human Food
NEW!
1:30 - 3:30pm Optional, no-charge, 2-hour “application session” to help attendees better apply the training learnings to their day-to-day work.
Continental breakfast, lunch and breaks will be provided.
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PCQI faculty for this training
Kathy Gombas will join the session based on class size Larisa Pavlick has 20 years of combined experience working within the dietary supplement industry and 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. |
Pricing/Registration
UNPA Member & MOU Partners: $895.
Non-Member: $1,095.
Materials:
All course manuals will be provided. Total course work is 20 hours.
Venue
Hyatt Place
3700 North Outlet Parkway
Lehi, Utah 84043
HOTEL WEBSITE - FOR RESERVATIONS
UNPA Member & MOU Partners: $895.
Non-Member: $1,095.
Materials:
All course manuals will be provided. Total course work is 20 hours.
Venue
Hyatt Place
3700 North Outlet Parkway
Lehi, Utah 84043
HOTEL WEBSITE - FOR RESERVATIONS
