About the Course
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)
Course Categories
-
Introduction to Quality Assurance and Quality Management Systems
- Lesson 1: Introduction to Quality and Quality Management Systems
- Lesson 2: PDCA model and ISO 13485
- Reading: How to implement the Continuous Improvement Cycle
- Reading: PDCA: the cycle that improves Quality Management in life sciences
About the Course
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)
-
Introduction to Quality Assurance and Quality Management Systems
- Lesson 1: Introduction to Quality and Quality Management Systems
- Lesson 2: PDCA model and ISO 13485
- Reading: How to implement the Continuous Improvement Cycle
- Reading: PDCA: the cycle that improves Quality Management in life sciences