Introduction to Vendor Qualification

Supplier or vendor qualification is a crucial component in compliance to 21 CFR 111. The FDA requires that manufacturers of dietary supplements must “qualify” each of their vendors but do not provide guidance on how a company is to perform this qualification. Supplier qualification principles also apply to subcontracted services affecting cGMP (manufacturing steps, packaging and labeling, testing and/or calibration services, storage and distribution, etc.) Any supplier qualification program must include two critical components:

1. Clearly defined specifications/requirements for all of these goods or services being purchased, and;
2. Objective evidence to show that your requirements are being consistently fulfilled.

This four-hour training will provide you with the tools, guidelines and information on best industry practices as well as offer guidance on how to achieve both of the above critical requirements in ways that will enable compliance with cGMP and make the most efficient use of your resources.

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

• What is required by the FDA under 21 CFR 111 and FSMA
• How to apply vendor qualification activities and requirements
• Supplier monitoring
• Supplier approval
• Tools and reference materials

This course is valuable for QA/QC, regulatory and compliance, laboratory, and other key personnel who are in charge of or a part of implementing a new or modifying an existing vendor qualification program into their dietary supplement companies’ operations. The course would also be useful for purchasing and production managers, who may be involved in the vendor determination process and could benefit from understanding some of the elements in qualifying a supplier.

Course instructors will be selected from the following:

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.

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.

Shawn Ludlow - Shawn Ludlow is a well-established NSF GMP instructor. He has created several third-party certified quality programs compliant with 21 CFR 111, ISO 9001:2000 and FAMI–QS.

With an undergraduate degree in chemistry, master’s degree in public health and experience working as an analytical chemist for several years, Shawn found his education and work experience combination to be a natural fit for dietary supplement manufacturers looking to improve their quality programs.