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 from 8:30 a.m. to 4:30 p.m. on Friday, May 31. Breakfast will be served at 8 a.m. It will be held in the Hogan Lovells office at 555 13th Street NW, Washington, D.C. 20004.

Click here to register for this training program. 

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 an 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.

Click here to register for this training program. 

Photo of Elizabeth Fawell Elizabeth Fawell

Partner, Washington, DC

Elizabeth Fawell navigates the detailed, and often complex, regulatory issues confronting food companies and helps them understand both the rules and various risks involved so that they can make informed business decisions. Elizabeth works with every segment of the food industry, including manufacturers, distributors, retailers, restaurants, and food service operators; and their trade associations.  Elizabeth’s work on behalf of food industry clients with the Food Safety Modernization Act (FSMA) since its inception and her understanding of Hazard Analysis Critical Control Point (HACCP) systems provides her with the experience and perspective needed as she counsels clients on how to comply with new requirements under the law. Elizabeth is a Preventive Controls Qualified Individual (PCQI) and has completed the FSPCA PCQI training.

Elizabeth knows how laws, regulations, and guidance documents are developed, interpreted, and enforced. Her extensive knowledge enables clients to prevent and respond to enforcement actions such as Warning Letters, Import Alerts, and agency investigations. She helps clients in determining whether an RFR is necessary and whether a recall is warranted. If so, she helps manage the recall to minimize business impacts. Elizabeth provides real-time advice during factory inspections, helps clients prepare 483 responses, and drafts inspection manuals. She also assists clients in lawfully and creatively promoting their products; such as the development of labels, claims, and website and promotional campaigns. Elizabeth also supports clients in advertising disputes and with responses to FTC and Attorney General investigations.

Elizabeth helps clients stay informed of and ahead of public policy issues and develops strategies for effective advocacy before regulators. She also counsels clients on compliance with Consumer Product Safety Commission (CPSC) safety standards, testing and certification requirements, and reporting obligations.

Elizabeth is a member of the Food and Dietary Supplements Committee of the Food and Drug Law Institute.

Photo of Maile Hermida Maile Hermida

Partner, Washington, DC

Maile Gradison Hermida represents all segments of the food industry and their trade associations. She has a keen understanding of the issues affecting the industry, from product development through production, distribution, and retail sale. Her core practice involves helping companies ensure they are in compliance with regulations from federal agencies such as the Food and Drug Administration (FDA) and U.S. Department of Agriculture. Maile also provides strategic advice on public policy issues, frequently involving agency rulemakings.

Maile has considerable experience with the FDA Food Safety Modernization Act (FSMA), having worked with numerous companies and trade associations on all aspects of the law since the day it was signed. She translates her in-depth knowledge of FSMA into practical solutions for companies working on implementation strategies. She also is a Preventive Controls Qualified Individual (PCQI), as well as a Food Safety Preventive Controls Alliance Lead Instructor for the PCQI training.

Additionally, Maile assists companies with matters involving regulatory enforcement. She helps clients navigate product recalls; government inspections; and other enforcement actions, such as Warning Letters and import detentions. Maile also advises clients on the development of label and advertising claims, as well as labeling requirements for foods and dietary supplements.

Maile is a frequent speaker and contributor to industry publications. Prior to joining Hogan Lovells, she served as a judicial clerk to the Honorable Charles F. Lettow of the U.S. Court of Federal Claims. Maile graduated with high honors from The George Washington University Law School, where she served as executive editor of The George Washington Law Review.