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Salt Lake City, Utah
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UNPA presents PCQI training: Preventive Controls Workshop for Dietary Supplements

Event Start Date: 7/17/2017

Event End Date: 7/19/2017

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Cost per place: $1,495.00

UNPA presents PCQI training:

Preventive Controls Workshop for Dietary Supplements

PCQI Training for Dietary Supplement Companies


July 17-19

Hilton Salt Lake City Center

Salt Lake City

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.


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 Preventative Controls for Dietary Supplements

This UNPA 2.5-day PCQI training course provides exercises specific to dietary supplements. The remainder of the 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. This person should have successfully completed training in the development and application of risk-based preventive controls.

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 be able to:

  • Discuss Good Manufacturing Practices and Prerequisite Programs
  • Conduct hazard analysis and determine preventive controls
  • Define process, allergen, sanitation and supply-chain preventive controls
  • Discuss 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.

 

UNPA’s PCQI Qualified Individual Workshop Agenda

Monday, July 17

7:30-8:30am Registration/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

Tuesday, July 18

7:30-8:00am Continental breakfast

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


Wednesday, July 19

7:30-8:00am Continental breakfast

8:00am - 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

 

Continental breakfast and breaks will be provided. Lunch is on your own.

 

Pricing/Registration

UNPA Member: $1,295.

Non-Member: $1,495.

 

Seating is limited to 30 participants.

 

Materials: 

All course manuals will be provided.

 

Venue and lodging

Hilton Salt Lake City Center

255 South West Temple

Salt Lake City, UT 84101

 

The venue is offering its “best rate” to PCQI training participants. Call the hotel directly at 801.328.2000 and ask to speak with "reservations." Use reservation code: UNPin order to obtain the discounted rate.

  

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