PCQI Training

Preventive Controls for Human Foods (PCQI)

Dates:
May 17-19, 2022 | 8:00am – 12:30pm MST (In-Person)
September 20-22, 2022 | 8:00am – 12:30pm MST (In-Person)
December 6-8, 2022 | 8:00-12:30pm MST (Virtual)

​Price:
Regular Rate: $1,799
UNPA Member Rate: $1,499
Discounts available for multiple participants

Register:
Contact Linda O’Dea, Regulatory and Event Coordinator, linda@unpa.com

COURSE DESCRIPTION

The Preventive Controls for Human Food (PCQI) virtual blended course, presented by United Natural Products Alliance, is a three day/four hours per day course. It is intended to ensure safe manufacturing/processing, packing and holding of food products for human consumption in the United States. The regulation requires that certain activities must be completed by a Preventive Controls Qualified Individual (PCQI) who has successfully completed training in the development and application of risk-based preventive controls. This course developed by the FSPCA is the “standardized curriculum” recognized by the FDA and meets the requirements for a “preventive controls qualified individual” (PCQI).

“A Preventive controls qualified individual “means 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 a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.” This is the definition is from Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation § 117.3 and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Food for Animals regulation § 507.3.” Food Safety Preventive Controls Alliance

“Under the Preventive Controls for Human Food rule, the responsibilities of a “preventive controls qualified individual” include to oversee or perform 1) preparation of the Food Safety Plan, 2) validation of the preventive controls, 3) records review, 4) reanalysis of the Food Safety Plan, and other activities as appropriate to the food. See § 117.180 and 507.53 for more details.” Food Safety Preventive Controls Alliance”

About the Instructor

larisa pavlick unpa united natural products alliance staff photo headshot bioCourse will be taught by Larisa Pavlick, UNPA’s Vice President Global Regulatory and Compliance. With over 25 years in the dietary supplement and natural products industry, Larisa is the ONLY instructor who has worked for the Food and Drug Administration. Her primary responsibility was to conduct inspections and investigations for dietary supplement firms and ingredient suppliers. She also has extensive industry knowledge in product development, quality, regulatory affairs, daily operations and technical purchasing. Her experience in the full product life cycle from development purchasing through manufacturing. She is a FSMA Preventive Controls for Human Foods Lead Instructor and is FDA trained and qualified to conduct GMP training. Her unique perspective will provide invaluable insight into the world of FDA audits.

View Larisa’s full bio >>

The PCHF rule applies to dietary supplement and natural products if:

  • The product is marketed or sold with a Nutrition Facts panel in the U.S.
  • You sell or purchase raw materials
  • You are a manufacturer responsible for qualifying suppliers of raw materials
  • You are a brand owner and you distribute in the U.S. You are ultimately responsible for the products under your labels even if you utilize contract manufacturers.
  • If you are importing products from a foreign supplier. You must ensure they meet all applicable food safety standards. Raw materials and food suppliers must be qualified using the PCFH rule.
  • All operations are required to have training specific to 21 CFR Part 117.4-Employee training
  • All operations are required to apply applicable sections from Subpart B-Good Manufacturing Practices which are above and beyond the requirements of 21 CFR
  • Part 111 DS-GMPs including allergen cross contamination prevention.
  • All companies maintain records covered under PCHF including training, written procedures for 117.420, and Foreign Supplier Verification Programs (FSVP).
  • It is highly recommended by UNPA that all companies are trained in Subpart G-Supply Chain Programs. Although dietary supplements are exempt from this section, this IS the FDAs modernized approach to supplier qualification. Everyone can benefit from this section.

Upon successful completion of this FSPCA course you will receive your PCQI certificate. This UNPA course will provide tools and insight to help you to interpret and implement this new Food Safety Modernization Act (FSMA) rule within your dietary supplement business. Upon completion you will have the skills and knowledge to:

  • Conduct the required written hazard analysis
  • Establish and implement a food safety plan
  • Prepare your operation for the FSMA PCQI regulations

The course is designed as a two-part course:

Part 1

Part 1 is an online eLearning including 16 self-paced modules of FSPCA curriculum

  • Will take approximately 6-12 hours to complete based on background and experience.. However, you have up to six months to complete all 16 modules.
  • If you do not participate in Part 2 after six months, you will be required to repeat Part 1. No refunds will be given.
  • Our current 2020/2021 training schedule includes conducting Part 2 PCHF courses on May 18-20, September 21-23 and December 2021.
  • Includes skills assessments and exercises related to hazard analysis and food safety plans.
  • Upon completion of Part 1 you will receive a certificate by email allowing you to participate in Part 2.
  • Part 1 must be completed prior to attending Part 2.
Part 2

The course will run from 8:00 am to 12:30 pm MST. As a participant you will receive Ms. Pavlick’s vast knowledge of the natural products industry. At the end of the course you will be able to:

  • Conduct hazard analysis and determine appropriate preventive controls
  • Define process, allergen, sanitation and supply-chain preventive controls
  • Discuss verification, validation, recall and record keeping requirements
  • Receive UNPA tools to apply this rule to your dietary supplement operation including an example Food Safety Plan for one of five key ingredient categories including various botanical models including green tea, Echinacea, or hemp, probiotic, fish oil.
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