21 CFR 117 for the Dietary Supplement Industry

Dietary supplement manufacturers may be exempt from the preventative control’s requirements of 21 CFR 117, but they are not completely exempt from all aspects of this new regulation. In this short training, we will highlight the aspects of 21 CFR 117 that apply to dietary supplement manufacturers and raw material suppliers. You will learn what new cGMP requirements in Subpart B of 21 CFR 117 are required for dietary supplement manufacturers and are now an extension of the cGMP requirements in 21 CFR 111.

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

• What FSMA is
• Where to find the new regulations
• What parts of 21 CFR 117 impact dietary supplement manufacturers and raw material suppliers
• The additional GMP requirements for dietary supplements found in 21 CFR 117 subpart B

Anyone from:

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

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.