FSPCA's PCQI - Preventive Controls for Human Food Version 2.0

This course is ideally intended for:

• Those responsible for performing or overseeing the preparation of the food safety plan.
• Food Safety & Quality professionals responsible for HACCP, QA/QC, or food safety programs.
• Regulatory and compliance staff needing to meet FSMA and FDA preventive control requirements.
• Anyone designated as a PCQI under FSMA who must develop, implement, or manage a food safety plan

• Chapter 0: Preface: Overview of the FSPCA Preventive Controls for Human Food
• Chapter 1: Food Safety Plan Overview for Preventive Controls for Human Food
• Chapter 2: Current Good Manufacturing Practice and Prerequisite Programs for Human Food
• Chapter 3: Biological Food Safety Hazards for Human Food
• Chapter 4: Chemical, Physical, and Economically Motivated Food Safety Hazards for Human Food
• Chapter 5: Preliminary Steps in Developing a Food Safety Plan for Human Food
• Chapter 6: Hazard Analysis for Human Food
• Chapter 7: Preventive Controls Determination for Human Food
• Chapter 8: Process Preventive Controls for Human Food – Parameters and Values, Including Critical Limits
• Chapter 9: Process Preventive Controls for Human Food – Monitoring and Corrective Action
• Chapter 10: Process Preventive Controls for Human Food – Verification and Recordkeeping
• Chapter 11: Food Allergen Preventive Controls for Human Food
• Chapter 12: Sanitation Preventive Controls for Human Food
• Chapter 13: Supply-Chain Preventive Controls for Human Food
• Chapter 14: Food Safety Plan Implementation and Management for Human Food
• Chapter 15: Recall Plan for Human Food
• Chapter 16: Regulation Overview – Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food

TÜV SÜD America conducts a 3-day Preventive Controls for Human Foods – PCQI training program as per Food Safety Preventive Control Alliance (FSPCA). The course, taught by FSPCA Lead Instructors, concentrates on FDA-recognized standardized curriculum. Our instructors will share their experiences and knowledge as per the standards requirement.

This training course is a standardized, industry-oriented training that provides participants with the knowledge that is needed to create a Food Safety Plan to comply with the Preventive Controls for Human Food regulation. The participant course content is focused on the food safety activities and documentation that support the creation and implementation of a preventive controls Food Safety Plan.

Purpose

Explore the regulatory requirements of the U.S. Food and Drug Administration’s (FDA) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.

Course Goal

Develop a Food Safety Plan and implement preventive controls to mitigate and control specific hazards.

At the end of the program, learners will be able to:

1. Describe the oversight of the preparation of Food Safety Plans.
2. Review the verification of preventive controls.
3. Review relevant records.
4. Analyze existing Food Safety Plans.
5. Recognize resources within the curriculum for development of a Food Safety Plan.

Version 2.0 Updates

Version 2.0 of the PCHF curriculum integrates information from the FDA's recently issued Hazard Analysis and Risk-Based Preventive Controls for Human Food draft guidance including updates to the hazard analysis course chapter which now includes use of the FDA’s Appendix 1 – Known or Reasonably Foreseeable Hazards and updates to the allergen chapter which now includes sesame.

This updated version of the course helps those who operate primarily under HACCP by improving the linkage between Preventive Controls and HACCP.

• Get introduced to the U.S. Food Safety System
• Understand Good Manufacturing Practices and Other Prerequisite Programs
• Understand the verification and validation Procedures
• Get and overview of the regulation including cGMP, Hazard Analysis and Risk-Based Preventive Controls for Human Food

Instructor-Led: Delivered live, in-person, and/or virtually by Lead Instructors trained by FSPCA, who have been instructed in how to teach the FDA-recognized standardized curriculum.

In this interactive training, we have incorporated a number of group activities that require us to utilize breakout rooms for group work and discussions. These types of activities reinforce better knowledge transfer and allow our learners to share experiences and knowledge. All participants will need to ensure they can join the web-based, live training via VoIP to participate in these activities.

Participants will receive an official FSPCA Preventive Controls Qualified Individual certificate issued by the Association of Food and Drug Officials (AFDO) after attending this training program.

The FSPCA training materials include the training manual including slides, explanations of key terms and concepts, exercises using Food Safety Plan Teaching Examples, exercise workbook, and reference material. The training materials are designed to meet the requirements for training under Title 21 Code of Federal Regulations (CFR) 117.180(c)(1) for the Preventive Controls Qualified Individual who conducts certain Food Safety Plan activities.

• Experience in food chain, HACCP, GMP, GHP, etc.
• Prior understanding of relevant food safety legislation & pre-requisite programs

Is the FSPCA PCHF V2.0 curriculum recognized by FDA as the standardized curriculum?

• Yes, the U.S. Food and Drug Administration (FDA) provided their official recognition of the FSPCA Preventive Control for Human Food V2.0 curriculum as the “standardized curriculum” on October 18, 2024.
• Successfully completing this course is one way to meet the requirements for a “preventive controls qualified individual.” Note: Under the Preventive Controls for Human Food rule, the responsibilities of a “preventive controls qualified individual” are 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.