QMS1101 Quality 101
Introduction course of QMS Program
Contents include: various concepts involved in quality, a brief history of quality, an overview of the ISO 9001 international standard for quality management systems, and hands-on projects to help you learn the various quality management elements involved in ISO 9001.
Through the course, you can have a preliminary understanding of quality management, be familiar with professional vocabulary, understand the basic principles, and lay a foundation for the study of subsequent courses. This course is also a litmus test for students to see if they are interested in pursuing a career in quality management.
QMS1103 Project Management
Contents include: core concept of project management, project start-up method, project plan, project implementation, acceptance and transfer, and project closure. In addition, it is equipped with case practice exercise, case analysis activity, feedback, and summary.
QMS1105 Lab Management and Experiment Design
Contents include: basic laboratory composition and daily operation, data integrity and good documentation practices, good laboratory practices, ISO 17025:2005 international standards for laboratory management, introduction to experimental design and introduction to experimental planning. Through the course learning, you can understand the organizational mode and quality management elements of laboratory management, and improve the efficiency of my own research projects.
This course is universal, explaining laboratory management and documentation related norms, and helping students to design and plan experiments. It is suitable for students majoring in biology, medicine, materials, chemistry, electronic information and other related majors.
QMS2203 Design and Development Control
Contents include: design project planning, demand investigation, demand decomposition, scheme design, risk management, verification testing, design and development control points of AI feature, confirmation of production and service process, document and record requirements, etc.
QMS2204 Audit Management and Supplier Control
Contents include: audit process introduction, third-party audit practice, internal audit practice, management review introduction, audit objectives and elements, audit cases, supplier management, etc.
QMS2205 Risk, Improvement, and V&V (RIVV)
Contents include: 1. Explore common misunderstandings and cognitive traps in people's understanding and perception of risk from the perspective of psychology; 2. 2. Take medical devices as a practical case to discuss software verification; 3. Discuss validation and verification; 4. Understand the meaning and goals of continuous improvement, discuss requirements and common tools.
QMS2206 Leadership and Management Review
This course combines the systematic knowledge of leadership and organization management with the actual requirements of industry management, and puts the theories of leadership and management into the execution level, focusing on operability. Develop systems thinking, understand the reasons behind management best practices, learn the underlying theory and practical tools to achieve effective promotion and operation of a quality management system, and practice the prescribed actions and corresponding tools required by the system. Choose a project carrier that even college students who lack actual industry experience can be familiar with to discuss and operate management practices.
QMS2301 Regulatory Requirements for Medical Devices (ISO 13485)
Contents include: Learn about the current state of the medical device industry at home and abroad, understand the regulatory requirements, and discuss ISO 13485, which is the most widely used international standard for medical device manufacturers to meet regulatory requirements, establish and maintain quality management systems (QMS).
QMS2303 Lean healthcare
For students who are interested in hospital management or lean thinking, this course will share the actual cases of lean management in hospitals in recent years. Through case discussion, the course will understand lean thinking and learn the application of lean tools.
Contents include: the history and development of lean healthcare, eight waste and cases, lean improvement tools and methods, the current situation and challenges of hospital management, hospital experts sharing, case study, etc.
QMS2304 Quality and Regulatory Requirements for Pharmaceuticals (for Human Use)
This course will introduce the basic regulatory and quality requirements for pharmaceutical product development and manufacturing. The course will explain the key elements of regulatory and quality requirements of CMC (Chemistry, Manufacturing and Controls), drug safety, and clinical trial in a life cycle of pharmaceutical product based on the ICH (The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) framework. The course will discuss scientific and technical aspects of pharmaceuticals from a regulatory and quality perspective. The course will also address China and US basic regulatory frameworks and their differences in governing pharmaceutical development and manufacturing, especially in the advanced therapy such as gene/cell therapy products.
The class is designed for student who have no or little knowledge of pharmaceutical regulations and GMP (Good Manufacturing Practice).
