Introduction to this course: 

Gain a high-level understanding of what a QMS is, its importance, and how to effectively establish and implement one. The course includes key concepts such as quality policies, objectives, and the Plan-Do-Check-Act (PDCA) cycle for continuous improvement. Additionally, you will receive a preliminary introduction to relevant standards like ISO 9001 and ISO 13485, and regulations such as 21 CFR Part 820. 

Who should attend: 

This course is designed for professionals in the pharmaceutical, biotech, and medical devices industries. 

Learning Outcomes: 

By the end of this lesson, you will be able to:

• Define the key components and principles of a Quality Management System (QMS)

• Describe the processes involved in implementing a QMS, including the development of quality policies and objectives.

• Explain relevant industry standards and regulations, and their application to quality management practices.

What will I gain: 

Participants will gain the fundamentals of Quality Management Systems tailored for the life sciences industry: key industry standards, regulations, and the core principles of a QMS.

Prerequisites: 

A basic understanding of the life sciences industry business. Familiarity with general quality management systems is beneficial but not required. No specific technical skills are necessary.

Additional information: 

Course duration: 00:19:50 

Course code/version (effective date): L-11/v1.0 (17/07/2023)