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Implementing a Regulatory Agile Quality Management System for Laboratory Developed Tests
November 20, 2021 @ 1:00 pm - 2:30 pm EST
Free
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P.A.C.E ® 1.5 Contact hour(s)
Description
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
Beginner
Course Objectives
1. Understand the rationale for a proactive approach to LDT oversight
2. Understand accreditation, regulatory and compliance requirements pertaining to LDT
3. Translate regulatory requirements into workable operational processes for the development of a quality management system
Instructor
Rita D’Angelo Ph.D.
The P.A.C.E. ® statement: D’Angelo Advantage is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program.
The webinar is conducted through Zoom. You’ll receive a Zoom link in your confirmation mail.
