Version 2.0 of the FSPCA Preventive Controls for Human Food participant course represents a significant update to the curriculum.

This updated version addresses important updates in FDA guidance documents; important knowledge that PCQIs will need to keep their Food Safety Plans up-to-date. In addition to FDA guidance updates, other updates in Version 2.0 include:

• Updated references, e.g., RFR, CDC

• Streamlined sections, reduced redundancy

• Better supports development of key concepts

• Expanded examples to better support application by small and mid-sized producers

• Gain recognition as an approved HACCP-based curriculum

The Preventive Controls participant courses developed by the Food Safety Preventive Controls Alliance (FSPCA) serve as the “standardized curriculum” that FDA recognizes as adequate; successfully completing this course is one way to meet the requirements for a “preventive controls qualified individual.”

The Current Good Manufacturing Practice, Hazard Analysis, and Risk‐based Preventive Controls for Human Food regulation (referred to as the Preventive Controls for Human Food regulation) 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.” This course, developed by FSPCA, is the “standardized curriculum” recognized by FDA; successfully completing this course is one way to meet the requirements for a “preventive controls qualified individual.”

The FSPCA Preventive Controls for Human Food (PCQI) course is essential for individuals involved in food safety management and compliance with the FDA's Food Safety Modernization Act (FSMA). Specifically, the following groups may need to take the course:

1. Food Manufacturing Facilities

  • Quality Assurance Managers: Responsible for implementing food safety plans.

  • Food Safety Managers/Coordinators: Oversee compliance with regulatory standards.

  • Production Managers: Involved in operations that may affect food safety.

  • Plant Managers: Oversee facility-wide food safety programs.

2. Supply Chain Partners

  • Raw Material Suppliers: Providing ingredients to food processors.

  • Contract Manufacturers: Producing food products for other companies.

  • Food Distributors: Handling storage and transportation of food.

3. Consultants and Auditors

  • Food safety consultants advising food facilities on compliance.

  • Third-party auditors assessing compliance with FSMA regulations.

4. Regulatory and Inspection Personnel

  • Government inspectors or regulatory officials ensuring adherence to FSMA standards.

5. Small and Medium-Sized Food Businesses

  • Owners or managers of small-scale food production businesses required to have a food safety plan in place.

6. Food Industry Stakeholders Seeking FSMA Compliance

  • Anyone needing to meet the FSMA requirement for a "Preventive Controls Qualified Individual" (PCQI) to oversee or prepare a food safety plan.