For food, supplement and hemp companies
September 4-6 | Denver, Colo.
September 4-6 | Denver, Colo.
Pricing/Registration
UNPA Member & MOU Partners: $1,095
Non-Member: $1,295
Only 40 seats available. Register today!
This class fulfills the FDA Requirement for a Preventive Controls Qualified Individual (PCQI) under The Food Safety Modernization Act (FSMA).
UNPA Member & MOU Partners: $1,095
Non-Member: $1,295
Only 40 seats available. Register today!
This class fulfills the FDA Requirement for a Preventive Controls Qualified Individual (PCQI) under The Food Safety Modernization Act (FSMA).
Dear Hemp Industry Colleague,
Hemp foods, hemp extracts and CBD fall under U.S. food law and all relevant regulations, including good manufacturing practices (GMPs), the Food Safety Modernization Act (FSMA), labeling and more. Many hemp-product companies are not aware of their legal obligations in this regard.
Specifically, this includes training your staff to establish a Preventive Control Qualified Individual (PCQI) under FSMA. What does this involve? Attending a 2.5-day course (which is rigorous) and obtaining a certification that your staff is competent to manage your company’s food safety programs required by law.
While the debate over the legal status of CBD continues, all hemp, food and supplement companies MUST take all steps to otherwise comply with these FDA regulations. Failure to do so could put your company in jeopardy and damage the prospects of CBD finding a lawful pathway going forward.
We urge you to attend and participate in this upcoming PCQI training, conveniently located in Colorado, to complete this essential training requirement.
With warm regards,
Loren Israelsen, President
United Natural Products Alliance
Hemp foods, hemp extracts and CBD fall under U.S. food law and all relevant regulations, including good manufacturing practices (GMPs), the Food Safety Modernization Act (FSMA), labeling and more. Many hemp-product companies are not aware of their legal obligations in this regard.
Specifically, this includes training your staff to establish a Preventive Control Qualified Individual (PCQI) under FSMA. What does this involve? Attending a 2.5-day course (which is rigorous) and obtaining a certification that your staff is competent to manage your company’s food safety programs required by law.
While the debate over the legal status of CBD continues, all hemp, food and supplement companies MUST take all steps to otherwise comply with these FDA regulations. Failure to do so could put your company in jeopardy and damage the prospects of CBD finding a lawful pathway going forward.
We urge you to attend and participate in this upcoming PCQI training, conveniently located in Colorado, to complete this essential training requirement.
With warm regards,
Loren Israelsen, President
United Natural Products Alliance
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Let's Talk Hemp: PCQI Training
A video interview with Larisa Pavlick, VP Global Regulatory & Compliance, UNPA and Colleen Keahay Lanier, Executive Director, Hemp Industries Association (HIA) Unabridged (21:43 minutes) Abridged (5:39 minutes) |
What is a PCQI?
A Preventive Controls Qualified Individual (PCQI) is defined in the PC Rule which reads in part "...a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under the standardized curriculum recognized as adequate by the FDA...." (21 CFR Part 117.3). The UNPA course will cover this "standardized curriculum" and so much more! Our course will apply these principles to products in the dietary supplement and natural product industry and will focus on botanically derived products and ingredients, such as hemp.
The UNPA course will focus on dietary supplements, foods and botanically derived ingredients used in the dietary supplement and food industry, including hemp. We will cover the standardized curriculum developed by the Food Safety Preventive Controls Alliance (FSPCA), and we will add additional information developed by UNPA, and with the assistance of subject matter experts, to help you implement the Preventive Controls rule for Human Food (21 CFR Part 117).
In addition to covering the Preventive Controls rule, the UNPA course will focus on the requirements of the Dietary Supplement Good Manufacturing Practices (GMPs) found in 21 CFR Part 111. We will cover how to be compliant with the dietary supplement GMPs, plus the modified requirements under 21 CFR part 117.
After taking the UNPA course, you will understand the biological, chemical and physical hazards reasonably likely to occur.
Why you should attend
Which subparts of the Preventative Rule (PC) apply to you?
In the UNPA course, we will provide tools to help you decode the FDA PC rule, and at a glance, you will understand which portions of the rule apply to your organization.
During the UNPA course, on day three, we offer additional information specific to the dietary supplement industry, potentially including dietary supplement claims and substantiation.
In addition to the UNPA designed tools, we will cover the applicable Food Safety Modernization Act (FSMA) FDA Guidance. These guidance documents will help you interpret the regulation, understand the agencies intent and current thinking and therefore to apply the PC rule appropriately to your operations.
The UNPA course will break down the PC rule for various dietary supplement types, including manufacturers, raw material suppliers and those purchasing finished dietary supplements. We will discuss the responsibilities of the brand owner that manufactures their own products, as well as the expectations for those using contract manufacturing.
If you are a manufacturer or a brand owner specifying the raw material to be used in your product, we will help you understand the regulatory expectation for qualifying your suppliers.
The Food Safety Modernization Act (FSMA) includes seven foundational rules. In the standardized curriculum, this course focuses on one of them; Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food. The UNPA course provides additional support for botanically derived ingredients, including an introduction to the Produce Rule and how it applies to raw materials and finished goods, dietary supplement GMPs and dietary supplement claims.
When you leave the UNPA course, we hope you will understand the PC rule and how it applies to a dietary supplement product/company from raw materials to finished goods. We also want you to be able to find the appropriate citation within the Final Regulation (21 CFR Part 117), especially those sections related to our industry.
We focus on the business of the business and we know supplements. The UNPA course is taught by former FDA staff, including a dietary supplement investigator. Training instructors can share their insight on the rule and how it applies to your business.
A Preventive Controls Qualified Individual (PCQI) is defined in the PC Rule which reads in part "...a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under the standardized curriculum recognized as adequate by the FDA...." (21 CFR Part 117.3). The UNPA course will cover this "standardized curriculum" and so much more! Our course will apply these principles to products in the dietary supplement and natural product industry and will focus on botanically derived products and ingredients, such as hemp.
The UNPA course will focus on dietary supplements, foods and botanically derived ingredients used in the dietary supplement and food industry, including hemp. We will cover the standardized curriculum developed by the Food Safety Preventive Controls Alliance (FSPCA), and we will add additional information developed by UNPA, and with the assistance of subject matter experts, to help you implement the Preventive Controls rule for Human Food (21 CFR Part 117).
In addition to covering the Preventive Controls rule, the UNPA course will focus on the requirements of the Dietary Supplement Good Manufacturing Practices (GMPs) found in 21 CFR Part 111. We will cover how to be compliant with the dietary supplement GMPs, plus the modified requirements under 21 CFR part 117.
After taking the UNPA course, you will understand the biological, chemical and physical hazards reasonably likely to occur.
Why you should attend
- The Food Safety Modernization Act requires you to have a Preventive Controls Qualified Individual (PCQI) in each of your facilities to establish, implement and manage the required, written hazard analysis and food safety plans (FSP) for all food products and ingredients, including hemp and hemp ingredients.
The PCQI is expected to have the education, background, training, and experience to understand the risks of the ingredient and manufacturing process to write and implement your FSMA FSP to ensure the manufacturing a safe food. FSMA also requires training on the Preventive Controls rule at least equivalent to the "standardized curriculum," which is taught in this course. - Regulators will ask for your FSP during an audit of your facility. FSPs may also be requested by your customers for review. If you are purchasing ingredients, you should be asking for them, too.
- The responsibilities of a PCQI include preparation of the FSP, validation of the preventive controls, review of records and reanalysis of the FSP every three years, or as necessary.
- Records review for your FSP must be reviewed by the PCQI within seven days. Multiple PCQIs may be necessary to satisfy records-review timeliness.
- A PCQI is an individual achievement and does not stay with the company. Do you have back up, a Plan B and support for this important position?
- A written hazard analysis is required for all food products and ingredients and most will require a FSP to manage potential hazards reasonably likely to occur. Hazard Analysis and a FSP are generated by your PCQI. A FSP is required if hazards are identified.
- Any company distributing a dietary supplement would be expected to qualify their supplier of 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 to manage their food safety.
Which subparts of the Preventative Rule (PC) apply to you?
In the UNPA course, we will provide tools to help you decode the FDA PC rule, and at a glance, you will understand which portions of the rule apply to your organization.
During the UNPA course, on day three, we offer additional information specific to the dietary supplement industry, potentially including dietary supplement claims and substantiation.
In addition to the UNPA designed tools, we will cover the applicable Food Safety Modernization Act (FSMA) FDA Guidance. These guidance documents will help you interpret the regulation, understand the agencies intent and current thinking and therefore to apply the PC rule appropriately to your operations.
The UNPA course will break down the PC rule for various dietary supplement types, including manufacturers, raw material suppliers and those purchasing finished dietary supplements. We will discuss the responsibilities of the brand owner that manufactures their own products, as well as the expectations for those using contract manufacturing.
If you are a manufacturer or a brand owner specifying the raw material to be used in your product, we will help you understand the regulatory expectation for qualifying your suppliers.
The Food Safety Modernization Act (FSMA) includes seven foundational rules. In the standardized curriculum, this course focuses on one of them; Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food. The UNPA course provides additional support for botanically derived ingredients, including an introduction to the Produce Rule and how it applies to raw materials and finished goods, dietary supplement GMPs and dietary supplement claims.
When you leave the UNPA course, we hope you will understand the PC rule and how it applies to a dietary supplement product/company from raw materials to finished goods. We also want you to be able to find the appropriate citation within the Final Regulation (21 CFR Part 117), especially those sections related to our industry.
We focus on the business of the business and we know supplements. The UNPA course is taught by former FDA staff, including a dietary supplement investigator. Training instructors can share their insight on the rule and how it applies to your business.
Event partner and host:
Supporting sponsor:
Media sponsors:
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
Westminster, Colo.
Sept. 4-6
Wednesday, Sept. 4
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
5:00-6:30pm TraceGains will host a wine and cheese happy hour.
Thursday, Sept. 5
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, Sept. 6
8:00-8:30am Continental breakfast
8:30am - 2:00pm
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
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
Westminster, Colo.
Sept. 4-6
Wednesday, Sept. 4
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
5:00-6:30pm TraceGains will host a wine and cheese happy hour.
Thursday, Sept. 5
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, Sept. 6
8:00-8:30am Continental breakfast
8:30am - 2:00pm
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
Continental breakfast, lunch and breaks will be provided.
PCQI faculty for this training
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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). |
Pricing/Registration
UNPA Member & MOU Partners: $1,095
Non-Member: $1,295
Only 40 seats available. Register today!
Materials:
All course manuals will be provided. Total course work is 20 hours.
UNPA Member & MOU Partners: $1,095
Non-Member: $1,295
Only 40 seats available. Register today!
Materials:
All course manuals will be provided. Total course work is 20 hours.
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Hotels
Download a PDF on hotels and travel info—TraceGains has a corporate code indicated on the sheet.
Download a PDF on hotels and travel info—TraceGains has a corporate code indicated on the sheet.
| travel_flyer[1].pdf |
Here’s another hotel option with a TraceGains discount code: Hilton
Doubletree: https://secure3.hilton.com/en_US/dt/reservation/book.htm?execution=e3s1
Doubletree: https://secure3.hilton.com/en_US/dt/reservation/book.htm?execution=e3s1