Expert training for healthcare, with emphasis on the diagnostic laboratory.

Full-Course: Developing a Quality Management System for Manufacture of Laboratory Developed Tests

Full-Course: Developing a Quality Management System for Manufacture of Laboratory Developed Tests

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4.0 Contact hours ($39.99)

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.

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

In this course, we will understand the development of a Quality Management System Framework through a step-by-step guide. This guide includes seven phases necessary to identify missing elements within the existing QMS and learn how to develop a robust framework for the development of LDT that comply with all requirements. Each phase includes an action item to prompt the learner that a task or activity is needed at that point.

Learning Objectives: As a part of this Course, the learner will complete the following:

  1. Understand the rationale for a proactive approach to LDT oversight
  2. Locate the accreditation, regulatory and compliance requirements pertaining to LDT
  3. Translate regulatory requirements into workable operational processes for the development of a quality management system

This course includes the following:

  1. Several short instructional video presentations
  2. Quiz-10 questions
  3. Assignment
    • Through this assignment, you will understand the steps to perform an assessment of your current quality management system. This assignment includes links to regulatory standards and an excel spread sheet. Each tab on the spreadsheet include forms listing activities as you go through the instruction. The excel tabs correlate with the information presented in the PowerPoint slides and also within the QMS “How to” guide. Feel free to follow along by reviewing the guide and forms throughout this course.

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


Virtual Group Instruction Available as a part of this course.

We provide live virtual classrooms to assist teams explore lessons in depth and apply the concepts to their live environment. The virtual classrooms includes weekly sessions with the instructor intended to allow teams to ask questions regarding the content, share lessons learned with other learners and brainstorm direction for change.

Course Materials: How to Guide: Developing a Quality Management System: Quality Management System LLS

Worksheet: Follow the Lecture Step by Step: LDT QMS Workbook Forms

Excel Form: Assignment: LDT QMS Assignment rev

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