Single-Course Engelsk 5 ECTS

Quality management and GMP

Overall Course Objectives

To get an understanding of the principles and structure in Quality Management, with a focus on Quality Assurance in regulated industries, Good Manufacturing Practice (GMP) and the pharmaceutical sector. The course is about quality management in every area of a company and how to be ISO certified with the pros and cons for the company. Students will gain insight into how the ISO system is working in a company daily business and how to create continuous improvement in company quality. The course will prepare the student for participating in ISO certified companies, complex systems and heavily regulated industries like the pharma industry.

See course description in Danish

To gain knowledge of the ISO standards related to quality management systems (which include quality assurance) and understand how such systems are structured and maintained.
Understand some of the quality-related ISO system structure and content
To use basic quality techniques
To be able to explain and perform simplified qualifications and validations
To be able to use quality tools in order to solve a quality problem
To understand and evaluate complex quality systems
Understand and explain the business advantages from quality management
To gain knowledge of administrative systems which is essential for the quality management system to work.
To understand and explain how quality assurance and management improve sustainability

Quality assurance in R & D
Quality assurance in production
Use of LEAN and Six Sigma in quality assurance
Optimization of company using quality tools
Quality assurance in administration
Quality in the health sector, pharma industry, GMP and traceability
Quality management systems, ISO, audits, deviations and maintenance of systems
Content of a quality hand book
Cases and assignments

Lessons, discussions, papers, exercises to test theories on the case descriptions.