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:
Clearly defined specifications/requirements for all of these goods or services being purchased, and; 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.
Learning Outcomes
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
Who Should Attend
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.
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