FSMA Supply Chain Programs 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 supply chain plan. This course focuses on the key obligations under 21 CFR 117 subpart G that are on products with a Nutrition Facts label.

Although dietary supplement manufacturers may be exempt from the preventative controls and supply chain program requirements of 21 CFR 117, raw material suppliers are not and many dietary supplement companies also manufacture products, such as meal replacements that are foods. These companies are not exempt and are required to have a written supply chain program as part of their food safety plan.

In this short training, we highlight the key requirements of 21 CFR 117 subpart G that are required for all raw material suppliers and any dietary supplement manufacturer that makes a product with a Nutrition Facts label.

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

• The components of a supply chain program
• Similarities and differences between FSMA-based supply chain programs and the supplier qualification requirements of 21 CFR 111
• What manufacturers and raw material suppliers need to do to be compliant with this part of the regulation.
• Where to find the new regulations under 21 CFR
• The complex requirements for supplier audits

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.