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Intentional Adulteration Mitigation (Food Defense)


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This course will teach participants the knowledge of what an organization is likely to expect in 2019 as the U.S. Food and Drug Administration (FDA) begins to implement enforcement of the Food Safety Modernization Act (FSMA) Rules 21 CFR 11 and 21 CFR 121, "Mitigation Strategies To Protect Food Against Intentional Adulteration." 

This is the only Food Defense advance level course led by two security professionals with over 30 years of combined practical supply chain experience in Intentional Adulteration mitigation. As security leaders in the consumer food industry, they have worked with the industry trade association from conception, through federal rule draft development and regulatory passage of the Intentional Adulteration Rule. Their partnership with senior-level executives and management in mentoring, coaching and providing value-added assessments is important to protect your organization's brands, products, shareholder value, reputation and consumers.

The course, through traditional delivery, interaction discussions, role-playing, breakout sessions and networking activities, will provide insight as to what actions industry peers are taking to prepare for the FDA 2019 Food Defense inspection implementation. Participants will learn the shortcomings, strengths and benchmarking standards of their industry peers.

Following completion of the course, participants should be able to complete a required vulnerability assessment to determine what, if any, mitigation actions are necessary to create a sustainable Food Defense Plan and assist in compliance upon inspection by the FDA.


Who should attend this course?

The corporate and facility senior-level person responsible for Food Defense compliance, organization success in daily implementation and execution and is also accountable for the results of the FDA Food Defense audits beginning in July 2019.

Benefits of attending:

Learn from two of the most knowledgeable and experienced Food Defense experts on how to prepare for July 2019 and what, if any, actions should be taken to minimize risk and secure your organization's brand, products, shareholder value, reputation and consumers. 

Take home valuable materials to help you in the process of compliance.


DURATION: 2.5 days

Dates & Location

View our current schedule of virtual or on-site courses at



Day 1: 8 am to 5 pm

  • Welcome – Continental Breakfast

  • Food Defense Quick Review – Roadmap to July 2019

  • Significant Changes

  • Insider Threat vs. Terrorism

  • Economic Adulteration

  • Training, Training and Training

  • Trusted Employees, Contractors, Temporary Workers, Consultants, Drivers, Etc.

  • Documentation, Documentation and Worksheets

  • Process Flow for Each Line, Product and or Both

  • Key Activity Types

  • Mitigation Strategies

  • New Food Defense Plan Requirements

  • What is Not a Food Defense Plan – GFSI, FSSC, SQF, HAACP, Food Safety, C-TPAT, BASC, AEO, C-FATS

  • What is a "Food Defense Qualified Individual"

  • Record Keeping and Documentation

  • Food Defense is Not Food Safety and Food Safety is not Food Defense – Adulteration vs. Intentional Adulteration

  • Wide Spread Casualties vs. One

  • Workshop / Round Table: Discuss Steps Taken to be Prepared for 2019, Surprises to Date and Concerns into 2019

Day 2: 8 am to 5 pm

  •  Continental Breakfast

  • Review Day 1

  • In-Depth Review of the Difference Between Hazard Analysis and Critical Control Point (HACCP) vs. Hazard Analysis and Risk-Based Preventive Controls, Section 103 of FSMA

  • Food Defense Plan Creation

  • Pre-Action Steps

  • KATs

  • Mitigation Strategies

  • Documentation

  • Vulnerability Assessment

  • Documentation that Stands on its Own

  • Signatures

  • Round Tables and Role Play – Discuss Shortcomings, How Closed and Surprises (Good and or Not So Good)

Day 3: 8 am to 2 pm

  • Continental Breakfast
  • Review Day 2
  • Likely Questions from FDA Inspectors in July 2019, and Recommended Responses
  • High-level Review of FDA's 94-page Draft Guidance for Industry of Mitigation Strategies to Protect Food Against Intentional Adulteration
  • Review FDA's Various Recommended Worksheets (Product Description, Monitoring, Mitigation Strategies, etc.)
  • Review Food Defense Assessment and Food Defense Plan Creation Software Tool


Judy Fadden - Food Defense Consultant with ABS Group

Mark E. Powers - Food Defense Subject Matter Expert with ABS Group

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