Full-Level: Developing a Quality Management System

6.0 Contact hours ($59.99)

Developing a Quality Management System for the Manufacture of Laboratory Developed Tests!

In this course, we explore the expansive industry that produces laboratory tests, reagents and protocols required to detect and treat illnesses referred to as “Laboratory Developed Tests (LDT). We discuss the history of LDT and the rationale behind the FDA proposal to reduce or eliminate the potential errors associated with LDT similar to requirements for manufacturers of medical device. We will also understand the rationale behind the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020 resurrected from Covid 19 testing concerns. For proactive compliance, we will learn the steps to develop a robust quality management system that will adhere to requirements for development of Laboratory developed tests. The learner will understand accreditation, regulatory and compliance requirements surrounding LDT and learn the process of a cross walk between the existing standards within the quality management system in comparison to regulatory requirements. We identify missing policies, procedures and processes to develop a Quality Management System Framework that will adhere to CLIA, comply with FDA pertinent regulations and expedite test development.

Upon completion of this course

1. Describe the rationale for a proactive approach to LDT oversight
2. Interpret the accreditation, regulatory and compliance requirement pertaining to LDT
3. Identify and translate regulatory requirements into workable operational processes for the development of a quality management system

This course includes:

1. Instructional video presentations
2. Quiz-10 questions
3. Assignment

Course assignment:

Assignment:  In this assignment, you will learn how to to develop or enhance your current Quality Management System (QMS). We begin by identifying missing elements within the existing QMS and learn how to develop a robust framework for the development of LDT that comply with all requirements.

Note: This assignment includes an “QMS How to ” guide that provides instruction correlating with the information presented in the video presentations. The intent is to follow along and complete the assignments step by step for the development of a Quality Management System Framework. Each phase includes an action item to prompt the learner that a task or activity is required.

The course includes links to regulatory standards.