Expert training for healthcare, with emphasis on the diagnostic laboratory.
4.0 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.
In this short course, we will learn the background of Laboratory Developed Tests and explore the FDA proposal to reduce or eliminate the potential errors and understand the rationale behind the FDA draft. We will learn a proactive approach to adopt accreditation, regulatory and compliance requirements and understand the steps to develop a robust quality management system that will adhere to these requirements for development of Laboratory developed tests. We will learn the method to develop a QMS structure that will align to regulatory requirements through seven stages of development. We learn how to perform a cross walk between the existing quality management system and regulatory requirements and identify missing policies, procedures and processes. We construct a redesigned regulatory QMS by a step by step guide will adhere to CLIA, comply with FDA pertinent regulations and expedite test development.