Education and Training

In an effort to help our members and the global dietary supplement industry be fully  compliant with all U.S. regulatory requirements and up-to-date on best practices, UNPA offers a variety of training courses and hosts regular conferences. Here you will find information regarding upcoming UNPA education and training opportunities —including new onsite training courses — as well as information regarding important regulatory requirements.

 

Learn more about UNPA education and trainings:

FSVP Training February 28-March 1 in Sandy, Utah
About FSVP Training
About PCQI Training
NEW! Onsite Training Courses

 



Foreign Supplier Verification Programs Course for Foods and Dietary Supplements

(two-day course)

Do you import ingredients?

This course is designed to help participants understand the role of food importers under the new Foreign Supplier Verification Programs (FSVP) rule, part of the Food Safety Modernization Act (FSMA).

Foods covered under the new rule include dietary ingredients, raw materials used in dietary supplements and natural products marketed with a Nutrition Facts panel as a food product.

The training covers the FSVP requirements for dietary supplements, including for raw materials distributors, manufacturers/processors importing components, and for those importing finished products from foreign suppliers.

Many importers are already outside of compliance with this law!

This regulation imposes sweeping new changes on food importers and requires the review and assessment of the food safety practices of foreign suppliers and their compliance history. Foreign suppliers must be approved by importers pursuant to a written program before sourcing. FDA’s regulation also requires new information to be submitted for customs entries: the FSVP importer—the person responsible for FSVP compliance—must now be declared for each importation of FDA-regulated food (including dietary supplements) unless exempt.

This course will provide participants with the knowledge to implement the requirements of the FSVP regulation. including:

  • Determining known or reasonably foreseeable hazards with each food imported
  • Evaluating the risk posed by the food (based on a hazard analysis and foreign supplier’s performance)
  • Using that evaluation to approve suppliers
  • Conducting supplier verification activities
  • Maintaining documents that are required to demonstrate compliance with the regulation.
Who or what falls under the FSVP requirement?
For the purposes of FSVP, an importer is the U.S. owner or consignee of a food offered for import into the United States. If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner of consignee at the time of entry, as confirmed in a signed statement of consent. See Am I Subject to FSVP? for more information.

About the course
This UNPA 2-day FSVP training course is designed to explain the FSVP rule and the requirements, including hazard analysis, evaluation and approval of a foreign supplier, importer identification, records and FDA oversight. The Food Safety Preventive Controls Alliance (FSPCA) developed this course in consultation with FDA, and therefore training is consistent with the intent of the rule. The rule states a “qualified individual” must perform your FSVP activities. This training is one way to meet the requirement.
  
At the end of this training program,
participants will be able to:
  • Explain the purpose of FSVP requirements
  • Define an FSVP importer and a foreign supplier
  • Describe the substances subject to and exempt from FSVP requirements
  • Describe the FSVP requirements (standard and modified) and to whom they apply
  • Discuss the importance of early communication between importers, foreign suppliers and others in the supply chain in meeting FSVP requirements
  • Understand the requirements for dietary supplements

This course meets FDA’s FSVP training requirements. Participants will receive an official FSPCA Foreign Supplier Verification Program certificate issued after attending this training program.

 

UNPA’s FSVP Qualified Individual Workshop Agenda

Wednesday, February 28

8:00am - 5:00pm
Continental breakfast

Welcome & Introductions

Chapter 1: Context: FSMA and FSVP

Chapter 2: Setting the Stage : Building the Foundation for the FSVP Process

Chapter 3: Overview of Requirements

Recap: Preventive Controls and Produce Safety Session

Chapter 4: Hazard Analysis

Day 2

8:00am - 5:00pm
Continental breakfast

Chapter 5: Evaluation and Approval of Foreign Supplier

Chapter 6: Foreign Supplier Verification

Chapter 7: Reevaluation of Foreign Supplier

Chapter 8: Importer Identification

Chapter 9: Records

Chapter 10: FDA Oversight

FSVP Faculty*

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.

* Larisa Pavlick is UNPA’s lead PCQI instructor. Other instructors will train with Larisa depending on class size. 

 


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About Preventive Controls Qualified Individual Training

The United Natural Products Alliance (UNPA) provides Preventive Controls Qualified Individual (PCQI) training for food and dietary supplement companies.
 
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

Day 1

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

Day 2

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

Day 3

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

PCQI Faculty*

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 PCQI training, please contact Kira Olsen, 801.474.2572.


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Larisa-in-Norway-adj-72dpi

UNPA’s Larisa Pavlick recently conducted onsite PCQI training for a client in Norway.

Indena attendees considered this FSMA/PCQI training very useful as a highly convenient way to understand the key points of this new law and regulations. Particularly, working together as an internal team on practical examples, we had the benefit of discussing and clarifying the questions relevant to our business that are unavoidable with any new regulation. It was also important for us to be trained by a person that is an expert in this specialized field of botanical extracts, who also has expertise from her work at FDA.

Ernesto Marco Martinelli,
Group-QA Manager & Regulatory for Indena