Intentional Adulteration (IA)

Dates:
TBD

​Price:
UNPA Member Rate: $1,550
Regular Rate: $1,850

Discounts available for multiple participants.

For more information contact Linda O’Dea, Regulatory and Event Coordinator, linda@unpa.com

Course Description

The FDA’s Food Safety Modernization Act rule: Mitigation Strategies to Protect Food Against Intentional Adulteration (21 CFR Part 121) (IA Rule) requires that covered facilities develop and implement a food defense plan that protects the facility’s most vulnerable points from acts of intentional adulteration intended to cause wide scale public health harm. The online class will target the FDA’s Key Activity Type (KAT), implement mitigation strategies at actionable process steps, and preparing and implementing a written food defense plan. The Instructor-led virtual session will provide the knowledge to implement the Vulnerability Assessment using the three fundamental elements requirements of the Food Safety Modernization Act rule: Mitigation Strategies to Protect Food Against Intentional Adulteration (21 CFR Part 121) (IA Rule).

Intentional Adulteration

  • The IA rule was designed to address the prevention of intentional adulteration to cause wide-spread public harm like illness, injury, death, or economic disruption in the U.S. food supply.
  • ​​The goal of the IA Rule is the systematic evaluation of operations including manufacturing and storage.


profile headshot ned mitenius periscope consulting llc food defense programsAbout the Instructor

Mr. 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.

Ned 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.  Ned is a member of the FSPCA Intentional Adulteration (IA) Subcommittee, chaired by the FDA.

Ned has traveled the world presenting Food Defense training with over 3000 participants from over 30 countries.  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.

Ned is a Lead Instructor and Trainer of Trainer for the FSPCA Instructor-led course for Intentional Adulteration, Vulnerability Assessments using the Three Fundamental Elements Approach.

This curriculum was developed in partnership with the Food Safety Preventive Controls Alliance (FSPCA), Intentional Adulteration Subcommittee (IA Subcommittee). Development was assisted by the International Food Protection Training Institute with funding from the Food and Drug Administration. The information provided by the FSPCA is for training purposes only and does not create binding obligations for FDA or industry. This course is intended as a training tool to assist companies in complying with the FDA’s Food Safety Modernization Act rule: Mitigation Strategies to Protect Food Against Intentional Adulteration (21 CFR Part 121) (IA Rule); however, taking this training does not ensure compliance with the law or FDA’s regulation.

Who Should Attend?

  • The IA rule is applicable to you in the food and dietary supplement industry.
  • “This part applies to the owners, operators or agent in charge of a domestic or foreign food facility that manufactures/processes, packs, or holds food for consumption in the United States and is required to register…” ((21 CFR Part 121.1)
  • Training is applicable for staff working in food, including dietary supplements and ingredients, manufacturing, packing, labeling, or holding including QA, QC, regulatory, manufacturing and operations staff. This course provides training for
  • operators and supervisors. Executive staff could attend to understand the regulatory responsibilities of the organization under this new FSMA rule. This includesProfessionals who conduct Vulnerability Assessments (VA) using the KAT method.
    • Professionals who identify Mitigation Strategies to implement an Actionable Process Steps.
    • Professionals who prepare the Food Defense Plan and/or who conduct Reanalysis activities.
    • Professionals who conduct VAs using the 3 Fundamental Elements.
    • All food facilities, foreign and domestic, that are required to register with the FDA under Food Facility Registration in the FD&C Act are covered by the requirements of the IA Rule. That is everyone!
    • July 2021 is the final compliance date for very small facilities. All other organizations should already be in compliance with the IA Rule.
    • The IA rule requires food facilities (including dietary supplement and ingredients) to develop and implement a food defense plan.
    • Individuals assigned to work at actionable process steps (APS) (21 CFR Part 121.3) and their supervisors are required to receive training in food defense awareness. APS are points where food processing is considered the most vulnerable to intentional adulteration. Based on studies and discussed in the Food Safety Preventive Controls Alliance standardized curriculum, processing steps which were consistently ranked high in vulnerability are
      • Bulk liquid receiving and loading (This suggests large quantities shipped and received in tanker quantities and potentially moved into “tank farms”)
      • Liquid storage and handling (This may include sweeteners, oils, or liquid ingredients)
      • Secondary ingredient handling (AKA dispensing of raw materials for use manufacturing)
      • Mixing and similar activities (this includes blending operations in a dietary supplement operations

 


Testimonials

“Ned was a great instructor. He commanded significant knowledge of the subject matter (expert), was clear in expectations of students, interacted accordingly and always encouraged participation. Virtual classroom for this type of training is an exceptional tool and should be continued with regard to all regulatory requirements.”
​-Kelly Pipoly, Quality Systems Lead, Lonza

“Ned did an outstanding job delivering the course content over two half days. Spreading the course over two half days made it easier to digest the information and think about how to apply the tools in respective jobs. Overall, great course. I actually had fun learning the course material. Instructional delivery and course content were spot on. I feel that I can confidently apply what I learned in my day-to-day function. I would highly recommend this course to others.”
​-Almisha Phillips, Quality Specialist II, Thorne

“Being able to participate in groups and discuss topics and get other members’ perspectives was the most valuable”
​-Tuyen Luong, Director of Quality Control/Quality Assurance, Allergy Research Group

“The Zoom class worked because of the ability to ask questions”.
-Chealse Walsh, Quality Assurance Supervisor Standard Process

 


The Online Training Includes

Conducting Vulnerability Assessments using Key Activity Types (KAT)

This online training course is targeted towards food professionals using FDA’s Key Activity Type (KAT) method to conduct their facility’s vulnerability assessment (VA). By successfully completing this course, the learner will have satisfied the training requirement to conduct a VA using the KAT method.​

Identification and Explanation of Mitigation Strategies

21 CFR Part 121 (IA Rule) requires covered facilities to identify and implement mitigation strategies at actionable process steps identified by a vulnerability assessment (21 CFR 121.135). The regulation further requires that individuals identifying and explaining the mitigation strategies “have successfully completed training for the specific function at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to conduct the activities” (21 CFR 121.4(c)(2)). This online training developed by the FSPCA is the “standardized curriculum” recognized by FDA; successfully completing this course is one way to meet this training requirement.

Food Defense Plan Preparation and Reanalysis

The regulation requires covered facilities to prepare, or have prepared, and implement a written food defense plan (21 CFR 121.126) and conduct a reanalysis of the food defense plan (21 CFR 121.157). The regulation further requires that individuals preparing the food defense plan and performing reanalysis “have successfully completed training for the specific function at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to conduct the activities” (21 CFR 121.4(c)(2)). This online training developed by the FSPCA is the “standardized curriculum” recognized by FDA; successfully completing this course is one way to meet this training requirement.

The Instricutor-Led Virtual Training:

This course will provide participants with the knowledge to implement the requirements of conducting a Vulnerability Assessment using the three fundamental elements under the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) regulation of the U.S. Food and Drug Administration (FDA). This regulation is one of a number of regulations and guidance that implement the provisions of the 2011 Food Safety Modernization Act (FSMA), which focuses on safe food practices.

This course taught by Lead Instructor, Ned Mitenius, and trained by the FSPCA has been instructed in how to teach the FDA-recognized standardized curriculum.

Be the first to know when trainings are scheduled by contacting Linda O’Dea, Regulatory and Event Coordinator, linda@unpa.com.

Registration is limited to 8 participants.

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