FSMA Intentional Adulteration Vulnerability Assessments Training Course

On May 31, Hogan Lovells will offer an important training program on conducting a vulnerability assessment under the Mitigation Strategies to Protect Food Against Intentional Adulteration final rule (IA rule), which is part of the FDA Food Safety Modernization Act (FSMA). This 1-day workshop will deliver the standardized “Conducting Vulnerability Assessments” training curriculum developed by the Food Safety Preventive Controls Alliance (FSPCA) with input from FDA.

The course will be taught by Hogan Lovells partners Elizabeth Fawell and Maile Hermida.  

Who should attend this training? 

Personnel from facilities and companies covered by the IA rule that want to understand how to conduct a vulnerability assessment using the three fundamental elements method or the “hybrid” method (which combines the Key Activity Type (KAT) method with the three fundamental elements method).

Participants will:
  • Learn in-depth about how to conduct a vulnerability assessment, including recommended preliminary steps, using the three fundamental elements and the “hybrid” approach.
  • Understand the role of the vulnerability assessment in the food defense plan.
  • Engage in interactive discussions and exercises to enhance your understanding of how to conduct a vulnerability assessment.
  • Review useful forms, templates, and resources for conducting vulnerability assessments.

Why attend the Hogan Lovells course?

  • Elizabeth Fawell and Maile Hermida have substantial FSMA experience and have been working on these issues since even before FSMA was enacted. In particular, they have been deeply engaged on the IA rule and how facilities can comply with its requirements for several years. Elizabeth was also one of the few Trainers of Trainers for this training program, reflecting her comprehensive expertise. 
  • Based on our experience with and understanding of existing food defense plans across the food industry, we can explain where companies need to revise their programs to be FSMA compliant and how to comply with the rule in a practical way.
  • Participants who successfully complete the program will receive the FSPCA’s course completion certificate. 

What are the compliance dates?  

  • July 26, 2019 is the compliance date for companies with more than 500 full-time-equivalent (FTE) employees.
  • July 27, 2020 is the compliance date for companies with less than 500 FTE employees.

​ Cost  

US$800 for each participant.

Additional notes 

  • The training program offers legal information, but will not provide legal advice specific to any company’s IA compliance. 
  • Participants are encouraged, though not required, to take the online course “Conducting Vulnerability Assessments Using the Key Activity Types” before attending this course. You can access the course here.
  • The IA rule requires that individuals conducting or overseeing the conduct of a VA “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 training developed by the Food Safety Preventive Controls Alliance (FSPCA) is the “standardized curriculum” recognized by FDA.  Successfully completing this course is one way to meet this requirement.  Therefore, completing this course is not mandatory for regulatory compliance; however, it will help you understand what you need to do to comply.
  • This training is open to non-firm clients.

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