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Monitoring for the FSMA Proposed Rule on Intentional Contamination

Instructor: Ned Mitenius
Product ID: 704451
  • Duration: 60 Min
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The program will discuss the practical development of an adequate monitoring program optimized to fit the Intentional Adulteration Rule. Attendees will learn the difference between monitoring, verification and validation. The program will review the existing Food Defense Plan Builder tool including its limitations and some possible changes. In the absence of a provided tool, the program participants will be shown how to create an effective monitoring program, and the documentation required to support it.

Why Should You Attend:

The Food Safety Modernization Act (FSMA) has resulted in several regulations, including one to guard against Intentional Adulteration (IA, also commonly called Food Defense). While the final rule is set to be published in May 2016, we can understand “monitoring” from the proposed IA rule, and from other similar final rules such as the Preventive Controls Rule for Human Food.

This session is designed for food defense and food safety practitioners who are preparing for implementation of the Intentional Adulteration Rule. Those who have existing food defense plans should understand how the monitoring requirements go beyond most existing food defense plans and what enhancements will be needed to comply with the rule. Operations which have relied on the FDA supplied Food Defense Plan Builder software tool should know the limitations of the existing tool, and how to overcome them.

Program participants may be familiar with monitoring for quality and food safety. This program will explain key differences anticipated in monitoring for food defense practices. Six specific recommendations will be provided to extend your existing (or planned) vulnerability assessment into an effective monitoring program.

Areas Covered in the Webinar:

  • What is FSMA and what is the proposed rule for intentional adulteration?
  • When is the final rule expected to be published?
  • What does IA proposed rule say about monitoring?
  • What does the final rule for preventive controls say about monitoring?
  • What is (and what is the difference) between monitoring, verification and validation?
  • What monitoring is documented within current the Food Defense Plan Builder software tool? What are the shortcomings?
  • What constitutes proper monitoring?
  • What documentation is needed for monitoring?
  • How is monitoring for food defense different than monitoring for food safety?
  • Is validation required?
  • Specific recommendations to go from a vulnerability assessment to a monitoring program

Who Will Benefit:

  • Food manufacturing leadership (plant managers and plant directors)
  • Quality and compliance personnel (plant and corporate)
  • Regulatory personnel

Instructor Profile:

Ned Mitenius, founder and president of Periscope Consulting, LLC, has been building food defense programs since 2003. Now Periscope Consulting has a global reputation in preparing Food Defense plans, conducting vulnerability assessments, creating tools and delivering education.

Mr. Mitenius built the models and exercises which became the FDA’s Food Defense Plan Builder tool. He and his team built the scenarios and instruction kit used in the USDA’s “Food Defense and Recall Preparedness: A Scenario-Based Exercise.” He has published an extensive blog series on the FSMA Intentional Contamination Rule.

He has traveled the world presenting food defense training for over 3000 participants from over 30 countries. His workshop participants include academic, industry, regulatory and national law enforcement agencies. He is the lead author of a food defense chapter in one textbook and a contributing author of another. He is an engaging speaker at many forums including IFT and the Food Defense Strategy Exchange. He has served on expert panels in support of FDA projects. In 2012, the team he traveled with globally was presented an FDA Agency Honor Award.

Recently Mr. Mitenius completed lead instructor training for the Human Food Preventive Controls course created by FSPCA (Food Safety Preventive Controls Alliance).

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