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
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.
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