Managing Suppliers in the Medical Device Industry
May 27 - 28, 2015 - San Diego NJ USAtlas Systems
Farhan.Kidwai@atlassystems.com
Phone:609 256 4556
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: Planning Selection potential suppliers Supplier evaluation and acceptance Establishing controls Delivery, measurement, and monitoring Feedback and communication, including Corrective Action and Preventive Action processes 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: Determining when a supplier is a contract manufacturer Deciding on a required QMS for a company that makes only components When to rely on the supplier’s third party QMS certificate When to conduct second party audits and establishing their scope Preparing suppliers for unannounced visits based on the MDD and EU expectations Creating requirements for UDI when the supplier is involved in the device label The role of medical device risk management, ISO 14971:2007, for component suppliers