PCQI Training - Preventive Controls for Human Food

PCQI stands for "Preventive Controls Qualified Individual." This is an individual responsible for overseeing the development and implementation of a food safety plan in compliance with the FDA's regulations, particularly under the Final Rule for Preventive Controls for Human Food. The PCQI plays a key role in validating preventive controls, reviewing records, reanalyzing the food safety plan, and approving deviations from the established program.

PCQI training, or Preventive Controls Qualified Individual training, is a specialized program designed to educate individuals on the development and implementation of food safety plans in accordance with the requirements of the Food Safety Modernization Act (FSMA).

Our course is completely online with no in-person requirements—no webinars, no travel, and no fixed schedule. All you need is an internet connection and a computer, tablet, or mobile device. Learn at your own pace: start, pause, rewind, or revisit the material anytime. It’s 100% flexible and 100% online.

PCQI training is essential for individuals responsible for developing and overseeing a company's food safety plan. This includes quality assurance professionals, food safety managers, plant managers and anyone involved in the production, handling, and distribution of food products.

The FDA's Final Rule for Preventive Controls for Human Food sets out food safety plan requirements for facilities involved in processing, manufacturing, holding, or packing food. If your company is required to register under Section 415 of the Federal Food, Drug, and Cosmetic Act, having a PCQI is mandatory. This individual is responsible for:

• Overseeing or developing the food safety plan

• Validating specific preventive controls

• Reviewing records

• Reanalyzing the food safety plan

• Approving deviations from the program

Failure to properly document or oversee these requirements may lead to a notice of violation from the FDA. Having a well-trained PCQI is crucial for ensuring compliance with FSMA regulations. It equips individuals with the knowledge and skills necessary to create and manage effective preventive controls and food safety plans, reducing the risk of foodborne illnesses and ensuring the safety of the food supply chain.

HACCP (Hazard Analysis and Critical Control Points) and PCQI (Preventive Controls Qualified Individual) are both systems designed to ensure food safety, but they differ in scope and application. Here is a very high level overview.

Scope: HACCP primarily focuses on hazard analysis and control points, whereas PCQI specifically addresses preventive controls under the FDA's Food Safety Modernization Act (FSMA) for human food.

Regulatory Framework: HACCP is a widely recognized international standard, while PCQI is mandated by the FDA for certain food facilities in the United States.

Legal Requirement: HACCP is required in some jurisdictions but not universally, while PCQI is required for companies registering under Section 415 of the Federal Food, Drug, and Cosmetic Act in the U.S.

Applicability: HACCP is applicable across the entire food industry globally, while PCQI primarily applies to facilities involved in processing, manufacturing, holding, or packing human food in the U.S.

Documentation: HACCP involves systematic documentation of hazard analysis and control points, whereas PCQI requires comprehensive documentation of a food safety plan, including preventive controls and monitoring.

The duration of the PCQI training program can vary, but it typically takes about 20 hours to complete. Our online training platform allows participants to progress at their own pace, giving them the flexibility to balance their training with other responsibilities.

The program provides comprehensive instruction on FDA’s Preventive Controls for Human Food Rule, covering:

1. Introduction & Foundational Concepts

• Course Introduction & Preventive Controls Overview

• Food Safety Plan Overview

• FSMA Regulations & Compliance Requirements

2. Prerequisite Programs & Food Safety Hazards

• Good Manufacturing Practices (GMPs)

• Prerequisite Programs (PRPs)

• Hazard Identification & Analysis:

  • Biological Hazards

  • Chemical, Physical, and Economically Motivated Hazards

3. Developing a Food Safety Plan

• Preliminary Steps in Plan Development

• Resources & Tools for Food Safety Plans

• Hazard Analysis & Preventive Controls Determination

4. Types of Preventive Controls

• Process Controls

• Food Allergen Controls

• Sanitation Controls

• Supply-Chain Controls

5. Verification, Validation & Compliance

• Verification & Validation Procedures

• Recordkeeping Requirements

• Recall Plan Development

6. Regulatory Overview

• cGMPs (Current Good Manufacturing Practices)

• FSMA’s Hazard Analysis & Risk-Based Preventive Controls

This structured approach ensures participants gain practical knowledge in designing, implementing, and managing a FSMA-compliant Food Safety Plan.

Yes, there are assessments at the end of each module to evaluate understanding and mastery of PCQI topics. Successful completion of the exam leads to the award of the certificate of completion.

Don’t worry! You can take the assessments as often as you’d like until you pass. This assessments are fun and interactive to enhance learning experience.

The certificate of completion that you earn after passing online PCQI training exam has no expiration date, however continued PCQI training is recommended.

To register, click on ENROLL NOW or ADD TO CART button on this page and follow the instructions for course registration and payment. If you encounter any issues, contact us here

Yes, we offer group discounts for organizations registering multiple participants. Contact us to request group rates.