Food Safety Plans and Hazard Analysis for the Dietary Supplement Industry

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.

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

Course instructors will be selected from the following:

Nicole Leitz - Nicole Leitz has 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 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.