Quality Management System for Laboratory Developed Tests

6.0 Contact hours. We learn a proactive, novel approach to build a new or modify an existing regulatory quality management system framework that will adhere to CLIA, comply with FDA pertinent regulations and expedite the development of Laboratory Developed Tests (LDT). We begin by understanding the regulatory requirements and perform a cross walk between the standards to identify missing policies, procedures, processes. We discuss the method to build a QMS by adopting the Stage Gate method to enhance the process for test development.                

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