21 CFR 121 Food Defense Plans for the Dietary Supplement Industry

Upcoming

Virtual Learning
July 14, 2022

1 day

Register
Virtual Learning
December 9, 2022

1 day

Register

About This Course

Food defense is a new area of compliance for the food industry and includes dietary supplement manufacturers. This training is an introduction to the 21 CFR 121 regulation focusing on how to create a compliant food defense plan for the dietary supplement industry as required by the FDA. This convenient short online training delivers extensive industry experience, real-world case studies and sample worksheets for immediate use with your business.

Key Learning Objectives

On completion of this course, you will know and understand:

  • Food defense plans and the required components
  • FDA interpretations of intentional adulteration in the dietary supplement industry under FSMA
  • How the 21 CFR 121 regulation applies to dietary supplement manufacturers and raw material suppliers
  • How to perform a vulnerability assessment with real-world examples

You will also receive FDA references and guidance documents.

Who Should Attend?

Anyone from:

  • Management
  • Manufacturing
  • Quality control/assurance
  • Packaging
  • Marketing
  • Laboratory operations
  • Auditing
  • Suppliers and distributors
  • Regulatory affairs

Instructors

Course instructors will be selected from the following:

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.

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.