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. This Webinar will identify the key elements of a robust, sustainable and successful supplier qualification program and why FDA is taking a closer look at purchasing controls and supplier qualification programs. 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. Although a manufacturer's knowledge of supplier operations may be limited and information about the operations difficult to obtain, the GMP requirement that a manufacturer is responsible for quality remains undiminished. To the maximum extent feasible, selection and qualification of suppliers by audits, performance analysis, surveys, etc., should be part of a quality system. Excluding a supplier whose components are unreliable from supplying components may help prevent problems with the final device and is certainly worthwhile as a cost reduction effort. Your system needs to provide performance metrics and reports that enable manufactures to identify top performing and underachieving suppliers based on an effective supplier scorecard or rating program. The system should capture metrics such as number of defects, quality of investigation, responsiveness to corrective action requests, on-time performance, batch rejections, quality deviations, and many other factors.
Objectives of the Presentation:
Who can Benefit:
- Discuss and review Supplier Agreements, Quality Agreements and other documentation including Contracts, etc.
- Learn how to apply risk-based approaches and why and how to "rank" suppliers based on criticality and RPN (Risk Priority Number)
- What to measure and how to measure supplier performance and assign classifications or levels
- Prepare and maintain the integrity of your Approved Supplier List
- Elements and sections that must be included in your SOP, checklists, and other areas you should emphasize, including your criteria for critical vs. non-critical or high-risk
- Classify suppliers based on the risks to the product, patient and liability exposure
- Understand what to document and how to prove and demonstrate that you have an effective supplier qualification program
- Learn what records are essential and required to present to any FDA investigator
- Update on recent FDA enforcement and trends regarding purchasing controls
This webinar will provide a valuable and informative overview and guidance to manufacturers, especially medical device companies that are preparing to establish or have established supplier/vendor management qualification programs and may need a refresher in order to make improvements to existing program. The employees who will benefit include:
Live Session - How it works
- All levels of management and departmental representatives any anyone who desire a better understanding or a "refresh" overview of the supplier evaluation and qualification process
- Regulatory Affairs/RA Specialists
- Technical Services/Operations
Recorded Session - How it works
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