The new FSMA regulation requires every processing facility to have at least one trained or experienced resource person or "Preventive Controls Qualified Individual- QI" who has completed a specialized training course such as the one developed by the Food Safety Preventive Controls Alliance (FSPCA) that is recognized by the FDA. This person will oversee the implementation of the facility’s food safety plan and other key tasks. (See 21CFR117.180 (c) (1))
Personnel associated with facilities registered with FDA, including processors, warehouses, packinghouses, distributors, handlers, importers, and others. Director/VP Food Safety, Maintenance Managers, Production Supervisors, Production Leads, Sanitation Supervisors, Plant Managers, Quality Assurance coordinators & Managers, Safety Managers, Training Supervisors, Lead Technicians, Packaging Supervisors & Managers, Auditors, Insurance and Marketing specialists, Regulatory Personnel, Extension personnel and Students.
Previous training in US cGMPs, Food Safety & HACCP, and knowledge of food processing and quality/safety is desired but not necessary.
The agenda is intended to be covered in a 2.5 days (~20 hours) course, including frequent opportunities for review and classroom exercises designed to provide learning opportunities for understanding Preventive Controls for Human Food regulation requirements. The time allotted to each section will vary based on the audience, level of familiarity and experience with Good Manufacturing Practices and risk-based food safety principles, as well as the food product and processing under consideration.
|Chapter 1||Introduction to Course, differences with PMO and Preventive Controls|
|Chapter 2||Food Safety Plan Overview|
|Chapter 3||Good Manufacturing Practices and Other Prerequisite Programs|
|Chapter 4||Biological Food Safety Hazards|
|Chapter 5||Chemical, Pysical and Economically Motivated Food Safety Hazards|
|Chapter 6||Preliminary Steps in Developing a Food Safety Plan|
|Chapter 7||Resources for Preparing Food Safety Plans|
|Review and Questions|
|Chapter 8||Hazard Analysis and Preventive Controls Determination|
|Chapter 8||Excercise (cont.)|
|Chapter 9||Process Prevention Controls|
|Chapter 10||Food Allergen Preventive Controls|
|Chapter 11||Sanitation Preventive Controls|
|Chapter 12||Supply-chain Preventive Controls|
|Review and Questions|
|Chapter 13||Verification adn Validation Procedures|
|Chapter 14||Record-keeping Procedures|
|Chapter 15||Recall Plan|
|Chapter 16||Regulation Overview - cGMP, Hazard Analysis, and Risk-Based Preventive Controls for Human Food|
|Appendices and Model Food Plans|