The FDA regulates manufacturers of medical products such as devices, pharmaceuticals, tissue products, and biologics. However, the regulations don’t usually extent to suppliers. Instead, the FDA expects the medical product manufacturer to implement an effective program to qualify and re-qualify suppliers for these regulated industries.
An effective supplier qualification program has some specific elements including determining expectations and requirements, identifying potential suppliers, evaluating them, selecting a supplier, and re-evaluating the selected suppliers. When issues arise, the manufacturer communicates with the supplier and manages corrective action.
The result is a supplier qualification program that address two principle questions:
This workshop explains an overarching supplier qualification program that is common to FDA regulated medical product manufacturers. It also provides the details of the various program areas such as devices, pharmaceuticals, etc.
An effective supplier qualification uses tools and techniques. The workshop explains particularly relevant tools such as supplier audits, metrics, scorecards, acceptance verification, and corrective action. These techniques help make the program FDA compliant and robust.
An effective supplier qualification program can prevent problems and save money. The goal is to ensure that competent suppliers provide products and services correctly and on time. This saves cost and helps you provide good products to your customers. In addition, an effective supplier qualification program meets the regulatory requirements; you will not need to worry about an FDA 483 or a Warning Letter. This workshop provides the information you need to establish and manage an effective program.
Participants learn the elements of an effective supplier qualification program for FDA regulated medical products.
Daniel O'Leary has more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Master’s Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.
Mr. O'Leary is a regular speaker at international conferences including ASQ, ISM, and RAMS. He teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Mr. O'Leary is an ASQ certified biomedical auditor, quality auditor, quality engineer, reliability engineer, and Six Sigma black belt; he holds an APICS certification in resource management.