Single-Course Dansk 5 ECTS

Quality management and GMP

Overall Course Objectives

To get an understanding of the principles and structure in Quality Assurance hereby also in regulated industries, GMP and the pharmaceutical sector. The course is about quality assurance in every area of a company and how to be ISO certified with the pros and cons for the company. Insight in how the ISO system is working in a company daily business and how to create continues improvement a company quality. The course will prepare the student in participating in ISO certified companies, complex systems and heavily regulated industries like the Pharma industry.

See course description in Danish

To understand and explain quality assurance systems based on the ISO standard. There structure and how they are maintained/updated.
To use basic quality techniques
To be able to use quality tools in order to solve a quality problem
Understand and explain the business advantages from quality assurance
Describe how quality is assured in every department and all levels in a company
To understand and evaluate complex quality systems
To be able to explain and perform simple validations
To gain knowledge of administrative systems which is essential for the quality assurance system to work.
Understand some of the ISO system structure and content
To understand and explain how quality assurance improves sustanability

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 I administration
Quality in the health sector, pharma industry, GMP and traceability
Quality assurance 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.