Two Day In-Person Seminar
Device manufacturers face issues and confusion when setting up and maintaining a supplier management program. Some of this confusion results from the regulations. While they contain requirements, the details are dependant on the device manufacturer’s ability to create an effective and efficient system.
This course helps the device manufacturer through a unique format of explanation, discussion, and practical application. The course is built of modules based on the Global Harmonization Task Force (GHTF) guidance document on the control of products and services obtained from suppliers. It describes the necessary controls in a model that includes six phases:
The course follows these phases and explains the regulatory requirements in the Quality System Regulation (QSR), ISO 13485:2003, the Medical Device Directive (MDD), EN ISO 13485:2012, and other requirements. Participants discuss each phase, using discussion points from the course material and apply multiple points of view: QMS implementers, internal auditors, external auditors, and FDA Investigators. Practical applications include situations, often based on FDA Warning Letters, in which participants work on methods to prevent the situation and to respond should it happen.
The course includes major topics that currently create problems. Among these are:
Upon course completion, participants will:
Meet Your Instructor
Dan O’Leary has more than 30 year’s experience in quality, operations, and program management in regulated industries including aviation, defence, medical devices, and clinical labs. He has a Masters Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.
Dan is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Dan 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.