UNPA presents PCQI training:
Preventive Controls Workshop for Foods and Dietary Supplements
PCQI Training for Foods and Dietary Supplement Companies
This class fulfills the FDA Requirement for a Preventive Controls Qualified Individual (PCQI) under The Food Safety Modernization Act (FSMA) and is limited to 30 participants!
View/download the program and agenda here or see below.
EARLY BIRD SPECIAL: If you register before midnight, August 8, you may use the following early bird codes to save $200 (non-members) and $300 (UNPA members). You must create an account or log in to register for this course.
Non-members use code: "PCQI Early Bird"
Members use code: "PCQI Early Member"
UNPA GMP/PCQI training is sponsored by
If most companies were asked, “Who is your PCQI?” (Preventive Controls Qualified Individual), there would be three typical responses:
1. What is PCQI?
2. I don’t know – I’ll ask around and get back to you.
3. Yes, we do have a PCQI. (PCQI is a person, not a thing!)
If an FDA investigator or a major customer were to ask this question, then what?
Preventive Controls for Human Foods is one of seven provisions of the Food Safety Modernization Act (FSMA) and the key to a new generation of food and dietary supplement GMPs based on the HACCP (Hazard Analysis Critical Control Point) principles of “anticipate, prevent, validate.” The old system was “problem, investigate, fix, repeat.”
Within the Preventive Controls for Human Food rule, a PCQI is required.
The Preventive Controls (PC) is the process, and Preventive Control Qualified Individual (PCQI) is the person trained to implement the preventive controls developed through a food safety plan.
Who or what falls under the PCQI requirement?
- All food products, wherever they are from, that are consumed in the U.S.
- Some companies are exempt (seafood, juice, low acid canned food, and Section 111 compliant dietary supplements).
If you produce, transport, distribute, warehouse, or sell DI/DS (Supplement Facts or Nutrition Facts labels), you are strongly advised to complete PCQI training.
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.
NOTE: Unlike most conferences, the strict requirements set up for this training by FDA and FSPCA mandate that all attendees fully participate in the 20 hours of training required to become a PCQI. Thus, no "stepping out" to take phone calls, or texting, responding to emails or web browsing is allowed during the 2.5 days of this training. Failure to adhere to these requirements could risk your ability to earn the PCQI certificate required to confirm your PCQI status.
Answers to Frequently Asked Questions regarding PCQI can be found here.
Read the UNPA article, "Who's your PCQI," regarding the importance of having a PCQI on your staff here.
UNPA’s PCQI Qualified Individual Workshop Agenda
Wednesday, August 16
8:00-8:30am Badge pick-up and continental breakfast
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
Thursday, August 17
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, August 18
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—GMP and Hazard Analysis and Risk-based Preventative Controls for Human Food
Continental breakfast and breaks will be provided. Lunch is on your own.
Larisa Pavlick joins UNPA with 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.
UNPA Member: $1,295.
EARLY BIRD SPECIAL: If you register before midnight August 8th, you may use the early bird code to save $200 (non-members) and $300 (members).
Non-members use code: PCQI Early Bird
Members use code: PCQI Early Member
All course manuals will be provided. Total course work is 20 hours.
Boulder Office Center
4845 Pearl East Circle
Boulder, CO 80301
4710 Pearl E Cir, Boulder, CO 80301
Call 303.440.4700 or visit the hotel website for reservations.
The hotel is located next door to the event venue.