Overview: One of the hottest topics facing the medical device industry is the evaluation and control of suppliers. Supplier management is typically a partnership between the purchasing department and the quality function. Different goals and objectives can also be a barrier including the quality function reporting into operations, a potential conflict of interest.
Purchasing controls for medical devices are defined in the Code of Federal Register (CFR) in 21 CFR 820.50. Component suppliers do not have an independent obligation to comply with the Quality System Regulation (QSR) as defined by the Food and Drug Administration (FDA). The onus lies on the finished device manufacturer to specify via a contract or purchase order the level at which suppliers must comply with the QSR. For many smaller suppliers compliance with the QSR is not cost effective, leading the finished medical device manufacturer to use auditing and inspection of components as the only method for controlling suppliers.
Areas Covered in the Session: Compliance with the FDA's purchasing controls can be defined in five (5) steps:
Determination of the level of control to exercise over the supplier
Recordkeeping or documentation of activities
Maintaining and/or disseminating purchasing information
Research and Development
Regulatory Affairs Personnel
Quality Assurance/Quality Control Personnel
Auditors and Inspectors
500 to 1000 people
Posted on Tuesday Feb 26, 2013
Mr Steven Walfish
Researcher at GlobalCompliancePanel
Mr. Steven Walfish is the President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to FDA regulated industries. Prior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD.
GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.\r\n\r\nGlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.