Full-Level: Developing a Quality Management System

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

6.0 Contact hours ($59.99)

Course Description

This course explores the vast industry responsible for developing Laboratory Developed Tests (LDTs)—including laboratory tests, reagents, and protocols used to detect and treat illnesses. We will examine the history of LDTs and the FDA’s proposed regulations aimed at minimizing errors, aligning LDT oversight with the standards applied to medical device manufacturers.

Additionally, we will discuss the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020, which was revived in response to concerns raised during COVID-19 testing. Learners will gain insight into proactive compliance strategies by exploring the steps needed to develop a robust Quality Management System (QMS) that meets regulatory requirements for LDT development.

This course will also provide a comprehensive understanding of accreditation, regulatory, and compliance requirements surrounding LDTs. Learners will engage in a crosswalk analysis, comparing existing QMS standardswith regulatory expectations. By identifying gaps in policies, procedures, and processes, participants will develop a QMS framework that aligns with CLIA standards, FDA regulations, and best practices—ensuring compliance and streamlining test development.

Who Should Take This Course

This course is ideal for laboratory technologists, technicians, administrators, quality roles and students looking to enhance their knowledge of quality management systems.

This Course Includes

• Engaging Instructional Videos – Gain in-depth knowledge through visual learning
• 10-Question Quiz – Test your understanding of key concepts
• Workbook, forms and links
• Course Assignment – Apply your newly acquired skills in a practical exercise

Course Agenda

• Introduction to Developing a Quality Management System
• Leadership & Training
• Pre-assessment of existing processes
• Phases of Development
• Design control & Process Control
• Stage Gate
• Process Validation
• Development of a Quality Management System

Learning Objectives

Upon completing this course, learners will be able to:

• Explain the importance of a proactive approach to LDT oversight and its impact on patient safety
• Interpret accreditation, regulatory, and compliance requirements related to Laboratory Developed Tests (LDTs)
• Convert regulatory requirements into practical, operational processes for building an effective Quality Management System (QMS)

Course Assignment

In this assignment, you will learn how to develop or enhance your existing Quality Management System (QMS) by identifying missing components and building a comprehensive framework for Laboratory Developed Tests (LDTs) that meets all regulatory requirements.

Note: This assignment includes a “QMS How-To” guide, which provides step-by-step instructions aligned with the course video presentations. Learners will follow along, completing each phase of the assignment, with action items prompting necessary tasks or activities.

The course also includes links to regulatory standards to support compliance and best practices.