FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct (as it relates to your product). FDA will deal with your company in case of product failure, especially as related to end user or patient safety concerns.
FDA has the right to see certain elements of your supplier qualification/purchasing controls related proof, i.e., the documentation. Learn why and how to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Understand why you need to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. Document this evaluation or assessment and define the type and extent of control to be exercised based on the evaluation results. You need to establish and maintain data that clearly describe or reference the specified requirements, including quality requirements. Identify the key elements of a robust, sustainable and successful supplier qualification program. The process is critical for device manufacturers to effectively evaluate and select suppliers and subsequently implement agreements ensuring consistent material quality and/or services provided. The process defines the elements associated with a supplier’s processes that are critical to quality. It also defines how conformance to manufacturer requirements will be monitored and verified.
Areas Covered in the Session:
Learn the pre-selection, selection and assessment process through the use of various tools
Methods, techniques and strategies that work and are proven with supplier relations and qualification
Learn how to apply risk-based approaches and why and how to “rank” suppliers
Supplier Agreements, Quality Agreements and other documentation including Audits/Assessments
What to measure and how to measure supplier performance and assign classifications or levels
Selection and qualification of suppliers by audits and performance analysis are part of your quality system
Approved Supplier List and areas to be targeted during the assessment or evaluation
Learn the elements of the SOP and the assessment of supplier capabilities