Course Details

Preventive Controls for Human Food (PCQI) Training Course

Introduction

The landscape of food safety has undergone a significant transformation with the introduction of the Food Safety Modernization Act (FSMA) in the United States, marking a paradigm shift from reactive response to proactive prevention. At the heart of FSMA is the requirement for food facilities to develop and implement a food safety system that includes a hazard analysis and preventive controls for human food. This mandate necessitates that facilities have a trained individual, known as a Preventive Controls Qualified Individual (PCQI), who is responsible for overseeing or performing the preparation of a food safety plan, validating preventive controls, reviewing records, and reanalyzing the food safety plan. The PCQI training course, standardized by the Food Safety Preventive Controls Alliance (FSPCA), provides the foundational knowledge required to develop and implement a compliant food safety plan under the Preventive Controls for Human Food regulation. Without a certified PCQI, food businesses importing to or operating in the US market face severe regulatory non-compliance, potential import detentions, and substantial penalties, in addition to the inherent risks of inadequate food safety management. Many food professionals understand traditional food safety concepts like HACCP but need specialized training to fully grasp the nuances of the new preventive controls approach, its specific requirements, and the role of the PCQI.

Conversely, mastering Preventive Controls for Human Food (PCQI) equips professionals with the essential knowledge and practical skills to develop, implement, and manage a compliant Food Safety Plan under the U.S. Food and Drug Administration's (FDA) Food Safety Modernization Act (FSMA) Preventive Controls for Human Food (PCHF) regulation. This critical certification is crucial for ensuring regulatory compliance, proactively preventing food safety hazards, minimizing risks, and facilitating market access to the United States. Our intensive 5-day "Preventive Controls for Human Food (PCQI)" training course is meticulously designed to equip food safety managers, quality assurance personnel, production managers, HACCP coordinators, and management with the comprehensive theoretical understanding and extensive practical, hands-on insights required to confidently serve as a PCQI and develop robust food safety systems.

Duration

5 Days

Target Audience

The "Preventive Controls for Human Food (PCQI)" training course is specifically designed for individuals who are responsible for developing, implementing, managing, and maintaining a food safety system for human food in accordance with the FSMA PCHF regulation. This includes:

• Food Safety Managers and Directors: Overseeing the entire food safety program.
• Quality Assurance (QA) Managers and Supervisors: Directly involved in system implementation and verification.
• HACCP Coordinators: Transitioning from HACCP to PC-based food safety plans.
• Production Managers and Supervisors: Responsible for implementing preventive controls on the plant floor.
• Regulatory Affairs Specialists: Ensuring compliance with FSMA regulations.
• Internal Auditors: Auditing FSMA-compliant food safety plans.
• Personnel responsible for preparing, validating, or reviewing food safety plans.
• Anyone whose facility is required to comply with the FDA's Preventive Controls for Human Food rule.

Course Objectives

Upon successful completion of the "Preventive Controls for Human Food (PCQI)" training course, participants will be able to:

• Understand the context of the FSMA PCHF rule and the role of the PCQI.
• Comprehend Good Manufacturing Practices (GMPs) and Prerequisite Programs as foundational elements.
• Conduct a comprehensive hazard analysis (biological, chemical, physical, radiological, allergen) for food products.
• Identify and establish appropriate preventive controls for various types of hazards.
• Develop and implement a complete Food Safety Plan compliant with FSMA PCHF.
• Understand verification and validation activities for preventive controls.
• Manage record-keeping requirements and perform reanalysis of the Food Safety Plan.
• Navigate the supply chain program requirements under the FSMA PCHF rule.

 Course Modules

Module 1: Introduction to FSMA and the Preventive Controls for Human Food Rule

• Overview of the Food Safety Modernization Act (FSMA) and its intent.
• Understanding the Preventive Controls for Human Food (PCHF) regulation.
• The role and responsibilities of the Preventive Controls Qualified Individual (PCQI).
• Differences between the PCHF rule and traditional HACCP.
• Scope of the PCHF rule and facilities subject to it.

Module 2: Good Manufacturing Practices (GMPs) and Other Prerequisite Programs

• Review of current Good Manufacturing Practices (cGMPs) as a foundation for food safety.
• Sanitation and hygiene programs relevant to food manufacturing.
• Pest control, allergen control, and maintenance programs.
• Supplier approval and raw material control programs.
• Building a robust Prerequisite Program (PRP) base for the Food Safety Plan.

Module 3: Hazard Analysis: Biological Food Safety Hazards

• Definition of a food safety hazard under FSMA.
• Introduction to biological hazards: Pathogenic bacteria (Salmonella, Listeria, E. coli), viruses, parasites.
• Factors influencing microbial growth and survival in food.
• Conducting a hazard analysis for biological hazards specific to food products.
• Risk assessment principles for biological hazards.

Module 4: Hazard Analysis: Chemical and Physical Food Safety Hazards

• Introduction to chemical hazards: Allergens, unapproved food additives, pesticides, natural toxins (e.g., mycotoxins), decomposition, drug residues.
• Physical hazards: Metal, glass, plastic, wood, stones, other foreign materials.
• Radiological hazards: Understanding their relevance in food.
• Conducting a comprehensive hazard analysis for chemical and physical hazards.
• Foreseeable hazards and intentional adulteration considerations.

Module 5: Preventive Controls

• Definition and types of preventive controls: Process, allergen, sanitation, supply-chain, other controls.
• Establishing critical parameters and critical limits for process controls.
• Developing allergen preventive controls to prevent cross-contact.
• Implementing sanitation preventive controls to prevent environmental pathogens.
• "Other" preventive controls, such as traceability or environmental monitoring.

Module 6: Food Safety Plan

• Components of a complete FSMA-compliant Food Safety Plan.
• Developing the hazard analysis and preventive controls for a specific food product/process.
• Writing monitoring procedures for preventive controls.
• Establishing corrective action procedures for deviations.
• Record-keeping requirements for the Food Safety Plan.

Module 7: Verification and Validation of Preventive Controls

• Validation of preventive controls: Scientific and technical basis for control effectiveness.
• Verification activities: Calibration, testing, environmental monitoring, review of records.
• Developing and implementing verification procedures.
• Reanalysis of the Food Safety Plan: When and how often it's required.
• Management of changes impacting the Food Safety Plan.

Module 8: Supply-Chain Program and Recall Plan

• Requirements for a robust supply-chain program under FSMA.
• Supplier approval, verification, and monitoring activities.
• When a supply-chain program is required versus other controls.
• Developing and implementing an effective recall plan.
• Mock recall exercises and emergency preparedness for food safety incidents.

CERTIFICATION

• Upon successful completion of this training, participants will be issued with Macskills Training and Development Institute Certificate

TRAINING VENUE

• Training will be held at Macskills Training Centre. We also tailor make the training upon request at different locations across the world.

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