Overview: 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.Areas Covered in the Session:Learn the pre-selection, selection and assessment process through the use of various toolsMethods, techniques and strategies that work and are proven with supplier relations and qualificationLearn how to apply risk-based approaches and why and how to "rank" suppliersSupplier Agreements, Quality Agreements and other documentation including Audits/AssessmentsWhat to measure and how to measure supplier performance and assign classifications or levelsSelection and qualification of suppliers by audits and performance analysis are part of your quality systemApproved Supplier List and areas to be targeted during the Who Will Benefit: All levels of Management and personnel from all departments who desire to learn how this process worksQA/QC/Compliance/Regulatory AffairsEngineering/R&D/Technical ServicesPurchasing/Procurement/SourcingConsultants Operations/Manufacturing/ValidationDavid R. Dills, an independent Regulatory & Compliance Consultant with more than 22 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory and compliance landscape.