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Implementing a Regulatory Agile Quality Management System for Laboratory Developed Tests
September 24, 2021 @ 1:00 pm - 2:30 pm EDT
One event on November 20, 2021 at 1:00 pm
In this 1.5 hour webinar you will learn the basics of a proactive approach to development of a quality management system for laboratory developed tests. You will understand the potential of regulatory requirements in the laboratory and will learn the background of laboratory developed tests. We discuss the framework of a regulatory quality management system as an organization structure that systematically define quality objectives linked to their broader strategic goals. We accomplish this by achieving these objectives through adopting of design controls and stage gate methodology.
Level of Instruction
Rita D’Angelo Ph.D.