About this course
This course covers food defense — protecting the food supply from intentional acts of adulteration, as distinct from traditional food safety, which addresses unintentional contamination. Learners work through what a food defense plan contains, how vulnerabilities are identified, and how mitigation strategies are monitored and verified.
The regulatory driver is FDA's Mitigation Strategies to Protect Food Against Intentional Adulteration rule, finalized on May 27, 2016 and codified at 21 CFR Part 121 (commonly called the IA Rule), one of the seven foundational rules of the FDA Food Safety Modernization Act (FSMA). It applies to owners, operators, or agents in charge of domestic and foreign food facilities required to register with FDA, with an exemption for very small businesses (currently defined as those averaging less than $10 million per year in food sales, adjusted for inflation). The rule requires a written food defense plan built around five components: a vulnerability assessment, focused mitigation strategies, procedures for monitoring those strategies, corrective actions, and verification.
This course is designed for QA managers, food defense coordinators, and plant leadership responsible for developing, maintaining, or auditing a facility's food defense plan.
After completing this course, learners will understand the three recognized categories of intentional adulteration (wide-scale public health harm, acts by disgruntled insiders, and economically motivated adulteration), be able to conduct or review a vulnerability assessment of significant vulnerabilities at actionable process steps, and know what monitoring, corrective action, and verification records a food defense plan must maintain to remain compliant.
Topics covered
- How food defense differs from food safety and HACCP
- Applicability and exemptions under 21 CFR Part 121
- The five required components of a food defense plan
- Identifying actionable process steps and significant vulnerabilities
- Monitoring, corrective actions, and verification recordkeeping
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