Food Safety Modernization Act (FSMA)

Currently there are no upcoming Food Safety Modernization Act (FSMA) courses scheduled. Contact us to find out when the next course will run or if you need customized training. We can deliver this course and a broad range of other training topics at your location, off-site or virtually.

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About This Course

The recent rule changes associated with the Food Safety Modernization Act (FSMA) will have a dramatic impact on the food safety and regulatory landscape for facilities producing products regulated by the FDA, and compliance deadlines for FSMA are quickly approaching. Although dietary supplements are exempt from the preventive controls requirements of 21 CFR 117, the preventive controls are just one part of the seven new rules implemented by FSMA.

Dietary supplements are still subject to other parts of 21 CFR 117 and are required to be compliant with the other applicable rules and regulations established under FSMA.

This FSMA training course will provide an introduction to all seven new rules and regulations established by FSMA and provide insight on which rules impact dietary supplement companies. The course will also provide tools, references and ideas for implementing the changes needed to comply with FSMA regulations.

Key Learning Objectives

At the end of the course, you will know and understand:

  • What FSMA is and where to find the new regulations
  • Who and what the FSMA requirements impact
  • Dietary ingredient suppliers
  • Dietary supplement manufacturers
  • Food manufacturers
  • Understand the difference between HACCP and HARPC
  • Understand what is required for:
    • Food safety plan
    • Hazard assessment
    • Risk-based preventive controls
    • Verification activities
    • Supply chain program
    • Foreign Supplier Verification Program
    • Food defense plan and adulteration
    • Sanitary transport requirements
  • Provide tools, references and ideas for implementing FSMA

Who Should Attend?

  • Management
  • Marketing
  • Quality control/assurance
  • Packaging
  • Laboratory operations
  • Product development
  • Suppliers and distributors
  • Regulatory affairs
  • Legal


Course instructors will be selected from the following:

Jennifer Alfrey - Jennifer is the Sr. Director Global Nutrition, PMO and NPD Process at Mary Kay. She has a master’s degree in nutrition and over 25 years of experience in the dietary supplement and cosmetic industries. Her experience ranges from product innovation to global regulatory compliance with experience in formulating, developing and registering nutrition and cosmetic products in over 150 different countries.

Jennifer has also successfully built cGMP compliant quality management systems from the ground up for dietary supplement manufacturing operations. She has launched quality systems that include compliant documentation of procedures, MMRs, specifications, complaints, laboratory testing, test method development and manufacturing processes.

Nicole Leitz - Nicole Leitz is Senior Partner of Validation & Compliance Institute (VCI) with more than 20 years of experience in the 21 CFR regulated industries. She has written and presented numerous training sessions on quality system elements and best cGMP practices to corporate clients and at national conventions. Nicole is also an experienced remediation consultant. She has advised and written documentation such as SOPs and WIs and has completed root cause investigations, CAPAs and complaints for corporate clients.

Nicole has a Master of Science degree in organic chemistry from Bucknell University and a Bachelor of Science in ACS chemistry from Hope College.