FDA Investigators have a sharp eye on your supplier management program. FDA’s approach is to regulate medical device manufacturers and expect them to regulate their suppliers. This places the burden squarely on you. In fact, FDA declared, “FDA will continue to focus its inspections on finished device manufacturers and expects that such manufacturers will properly ensure that the components [and services] they purchase are safe and effective. Finished device manufacturers who fail to comply … will be subject to enforcement action.”
A robust supplier management program will help improve production processes, reduce scrap/rework, and lower the complaint rate. In addition, a solid program will help you avoid an FDA 483, a Warning Letter, and all of the extra work that comes with them.
In this course, you will learn FDA’s requirements for supplier management. In FDA’s view this includes supplier selection, specification of the purchased components or services, and verification of the items received. To help understand these expectations, the course uses the regulations, their explanation in the QSR preamble, the GHTF guidance document, and Warning Letters that illustrate the issues.
Join our interactive online training course where you will find out the required quality management structure for your supplier program. You will learn:
This course will help your organization ensure an integrated, efficient, and complaint system.
This course will benefit all personnel who are involved in the supplier management process. People who will find this course of particular benefit include:
Dan O'Leary is President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan 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 Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and certified by APICS in Resource Management.