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Subscribe NewsletterSupplier Risk Management
Product Id
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600089
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.
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:
- Supplier evaluation
- Determination of the level of control to exercise over the supplier
- Recordkeeping or documentation of activities
- Maintaining and/or disseminating purchasing information
- Receiving acceptance activities
Who Will Benefit:
- Management
- Research and Development
- Regulatory Affairs personnel
- Quality assurance/quality control personnel
- Auditors and inspectors