Full-Course: Developing a Quality Management System

6.0 Contact hours ($59.99)

Greetings and Welcome to 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 will understand the rationale behind the FDA 2014 draft 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.

 

Who Should Take This Course:

This course is designed to teach new skills to laboratory managers, administrators, techs and all other employees.

 

Learning. Objectives:

1. 1. Describe the rationale for a proactive approach to LDT oversight

1. 1. Interpret the accreditation, regulatory and compliance requirements pertaining to LDT

1. 1. Identify and translate regulatory requirements into workable operational processes for the development of a quality management system

This course includes the following:

1. 1. Instructional video presentations – several videos to describe QMS topics

1. 1. Quiz-10 questions

1. 1. Assignment

Course Assignment:

In this course, we will use a step-by-step guide for the development of a Quality Management System Framework. The guide includes seven phases. Each phase includes an action item to prompt the learner that a task or activity is required.

Assignment: You will perform an assessment of your current quality management system (QMS) to develop or enhance the current QMS. By identifying missing elements within the existing QMS, you will learn how to develop a robust framework for the development of LDT that comply with all requirements. The 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. The course includes links to regulatory standards.

References:

D’Angelo, Rita, “An Agile Quality Management System For Laboratory Developed Tests” (2018). Wayne State University Dissertations. 1920.
https://digitalcommons.wayne.edu/oa_dissertations/1920

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