Single-Course Danish 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.

Learning Objectives

  • 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

Course Content

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

Teaching Method

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

Faculty

Remarks

Research group: Production, Transportation and Planning
Produktion: 3. semester

Mandatory assignments must be approved/passed in order to take the exam.

See course in the course database.

Registration

Language

Danish

Duration

13 weeks

Institute

Engineering Technology

Place

DTU Ballerup Campus

Course code 62107
Course type Graduate Engineer
Price

7.500,00 DKK

Registration