2 Ways to Look at Vulnerability Assessments - Part 1 and Part 2

Why Should You Attend:

The webinar will discuss the practical performance of an adequate vulnerability assessment designed to fit the Intentional Adulteration rule. Attendees will learn two different methods proposed by the rule, and the impact of choosing each one.

The term “qualified individual” will be discussed, and compared to what is published in the final rules for Preventive Controls in Human Food. When you may not need a qualified individual – and the ramification of making this choice – will be explained.

The program will review the existing Food Defense Plan Builder tool including its limitations and some possible changes. In the absence of an updated tool, the program participants will be shown how to overcome some of the limitations.

Program participants may be familiar with current hazard analysis methods. This program will explain key differences anticipated in vulnerability assessments for food defense practices. The term “actionable process steps” will be explained and its impact on performing a vulnerability assessment. Specific recommendations will be provided to choose between two alternatives provided by the proposed rule.

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 vulnerability assessments?
• What is (and what is the difference between) actionable process steps, key activity types, vulnerability assessment and focused mitigation strategies?
• What tools are provided for vulnerability assessments, and the strengths and weakness of each.
• One way to improve the results of the existing Food Defense Plan Builder vulnerability assessment.
• Specific recommendations to go from a vulnerability assessment to a monitoring program.

Who Will Benefit:

• Food manufacturing leadership
• Plant managers
• 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).

Topic Background:

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 vulnerability assessments from the proposed IA rule, and from existing FDA tools.

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