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Overview: 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. 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 Who Will Benefit: The employees who will benefit include: All levels of Management and personnel from all departments who desire to learn how this process works QA/QC/Compliance/Regulatory Affairs Engineering/R&D/Technical Services Purchasing/Procurement/Sourcing Consultants Operations/Manufacturing/Validation David R. Dills, Regulatory Affairs & Compliance Consultant currently provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems. Quick Contact: GlobalCompliancePanel USA Phone:800-447-9407 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Event Link - http://bit.ly/1cwfFey
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