Vendor Qualification and Audit Training

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 eight-hour vendor qualification audit training will help you improve quality in your facility. It is designed for those who already have a basic understanding of dietary supplement GMPs and the knowledge and skills necessary to qualify suppliers.

Since the evaluation of all types of suppliers often involves auditing, this course will incorporate a fresh look at the auditing process and the skills and techniques needed to get the most from these activities. The skills and techniques learned are independent of the type of auditing or the standard being audited and will be useful when conducting internal audits and performing audits of suppliers.