Food Safety Plans and Hazard Analysis for the Dietary Supplement Industry

Currently there are no upcoming Food Safety Plans and Hazard Analysis for the Dietary Supplement Industry 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

Dietary supplement manufacturers and raw material suppliers are not exempt from all the requirements of 21 CFR 117 and may be required to have a written food safety plan.

Combining extensive industry experience and concrete understanding of regulations with flexible and convenient training, this course covers the key obligations under 21 CFR 117 subpart C on products with a Nutrition Facts label.

Key Learning Objectives

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

  • The components of a food safety plan and what raw material suppliers need to do to be compliant
  • Identify where to find the new regulations under 21 CFR
  • The additional GMP requirements for dietary supplements found in 21 CFR 117 subpart B

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.