Introduction

In response to the paradigm shift in global food safety regulations, particularly the emphasis on prevention rather than reaction introduced by the Food Safety Modernization Act (FSMA), understanding and implementing risk-based preventive controls is no longer optional but a fundamental requirement for any food facility producing food for human consumption. Mastering Preventive Controls for Human Food (PCQI Training) is absolutely critical for food manufacturers, processors, packers, and holders who must comply with the FDA's stringent regulations, ensuring a proactive approach to identifying and mitigating food safety hazards throughout the entire production lifecycle. This essential training course is designed to equip food safety professionals, quality assurance managers, production supervisors, regulatory affairs specialists, and technical personnel with the specialized knowledge and practical skills required for developing and implementing comprehensive Food Safety Plans, conducting thorough hazard analyses, establishing effective preventive controls (process, allergen, sanitation, supply chain), mastering verification and validation procedures, and fulfilling the responsibilities of a Preventive Controls Qualified Individual (PCQI). Participants will gain a comprehensive understanding of the legal obligations under the FSMA Preventive Controls for Human Food Rule, the nuances of identifying and controlling diverse hazards (biological, chemical, physical, radiological, economically motivated), the challenges of record-keeping and regulatory audits, and the critical role of a well-defined Food Safety Plan in safeguarding public health and maintaining market access. This program utilizes the FDA-recognized standardized curriculum, empowering you to confidently manage your facility's food safety system.

Target Audience

• Food Safety Managers & Coordinators
• Quality Assurance (QA) & Quality Control (QC) Personnel
• Production & Operations Supervisors
• Technical Managers in Food Manufacturing
• HACCP Team Leaders & Food Safety Team Members
• Regulatory Affairs & Compliance Officers
• Consultants providing food safety services
• Individuals designated as the Preventive Controls Qualified Individual (PCQI)

Course Objectives

• Master the regulatory requirements of the FDA's Preventive Controls for Human Food Rule.
• Learn sophisticated techniques for developing a robust, risk-based Food Safety Plan.
• Develop proficiency in conducting comprehensive hazard analyses (biological, chemical, physical, radiological, economically motivated).
• Understand advanced strategies for identifying and establishing process preventive controls, including critical limits.
• Explore best practices in implementing effective food allergen preventive controls to prevent cross-contact.
• Grasp advanced techniques for establishing and monitoring sanitation preventive controls, including environmental monitoring.
• Learn about robust approaches to developing and managing a risk-based supply chain program.
• Identify the critical role of verification and validation activities for all preventive controls.
• Develop skills in managing essential record-keeping procedures for compliance.
• Understand the components and importance of a robust recall plan.
• Formulate strategies for reanalysis of the Food Safety Plan and continuous improvement.

Duration

5 Days

Course Outline

Module 1. Introduction to the Preventive Controls Rule

• Overview of the Food Safety Modernization Act (FSMA) and its preventive approach
• Key provisions of the Preventive Controls for Human Food Rule (21 CFR Part 117)
• Understanding the role and responsibilities of a Preventive Controls Qualified Individual (PCQI)
• Overview of a comprehensive Food Safety Plan and its components
• Exemptions and modified requirements under the rule

Module 2. Current Good Manufacturing Practices (cGMPs) & Prerequisite Programs

• Review of cGMPs as foundational prerequisite programs for food safety
• Personnel hygiene and training requirements
• Facility design and maintenance for hygienic operations
• Equipment design, maintenance, and calibration
• Sanitation, pest control, and water safety

Module 3. Food Safety Hazards: Identification & Characterization

• Biological food safety hazards: bacteria, viruses, parasites, fungi
• Chemical food safety hazards: allergens, heavy metals, pesticides, cleaning chemicals, natural toxins
• Physical food safety hazards: glass, plastic, metal, wood
• Radiologically and Economically Motivated Adulteration (EMA) hazards
• Understanding hazard likelihood and severity

Module 4. Hazard Analysis & Preventive Controls Determination

• Systematic approach to conducting a comprehensive hazard analysis
• Determining which identified hazards require a preventive control
• Introduction to types of preventive controls: process, allergen, sanitation, supply-chain, and other controls
• The scientific basis for preventive control effectiveness
• Establishing parameters and values for preventive controls (e.g., critical limits)

Module 5. Process, Food Allergen & Sanitation Preventive Controls

• Module on Process Controls: Designing controls for cooking, cooling, acidification, and other thermal/non-thermal processes; monitoring parameters and corrective actions.
• Module on Food Allergen Controls: Preventing allergen cross-contact, validating cleaning, proper labeling, and supplier management for allergens.
• Module on Sanitation Controls: Procedures to maintain sanitary conditions, environmental monitoring (if applicable), and preventing contamination from personnel.
• Other preventive controls specific to the facility's operations.
• Effective monitoring procedures for each control.

Module 6. Supply-Chain Preventive Controls & Verification

• Module on Supply-Chain Controls: Developing a risk-based supply-chain program for raw materials and ingredients requiring preventive controls.
• Supplier approval and verification activities: audits, certificates of analysis, testing.
• Verification activities for preventive controls: validation, calibration, record review, product testing, environmental monitoring.
• Establishing corrective actions for deviations from preventive controls.
• Reanalysis requirements for the Food Safety Plan.

Module 7. Record-Keeping, Recall Plan & Regulatory Overview

• Essential record-keeping procedures for Food Safety Plans, monitoring, and corrective actions
• Record retention requirements and accessibility for regulatory inspection
• Developing a robust written recall plan: notification, effectiveness checks, disposition of recalled food
• Overview of FDA inspection processes and expectations
• Building a strong food safety culture to support preventive controls implementation

Training Approach

This course will be delivered by our skilled trainers who have vast knowledge and experience as expert professionals in the fields. The course is taught in English and through a mix of theory, practical activities, group discussion and case studies. Course manuals and additional training materials will be provided to the participants upon completion of the training.

Tailor-Made Course

This course can also be tailor-made to meet organization requirement. For further inquiries, please contact us on: Email: info@skillsforafrica.org, training@skillsforafrica.org  Tel: +254 702 249 449

Training Venue

The training will be held at our Skills for Africa Training Institute Training Centre. We also offer training for a group at requested location all over the world. The course fee covers the course tuition, training materials, two break refreshments, and buffet lunch.

Visa application, travel expenses, airport transfers, dinners, accommodation, insurance, and other personal expenses are catered by the participant

Certification

Participants will be issued with Skills for Africa Training Institute certificate upon completion of this course.

Airport Pickup and Accommodation

Airport pickup and accommodation is arranged upon request. For booking contact our Training Coordinator through Email: info@skillsforafrica.org, training@skillsforafrica.org  Tel: +254 702 249 449

Terms of Payment: Unless otherwise agreed between the two parties’ payment of the course fee should be done 10 working days before commencement of the training.