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Quality Management and Production II
Last Updated: 2026-02-05 16:06:46
Abstract
This course highlights current areas of quality management and production in the biotech and pharmaceutical industry. Professionals from industry and from the health authorities discuss real-life examples and trends in their areas of expertise.
Objective
The students understand 'Quality Management & Production' in the biotech and pharmaceutical practice. Following topic-related introductory lectures, the students learn how to analyse given 'real life'-situations to propose a course of action, which is discussed in the light of current practices. Students - can analyse advanced quality-by-design cases. - understand quality issues of biotech drugs. - can discuss continuous manufacturing and quality management during the product's life cycle. - know how to successfully conduct and host audits or inspections of good manufacturing practice (GMP)
Content
The course uses expert input and case studies to provide up-to-date knowledge about quality-by-design, continuous manufacturing, product life cycle and biologicals. Furthermore, students learn how to conduct and host GMP-related audits and inspections and important dos and don’ts.
Resources
Lecture Notes
Handouts as electronic files
General Information
- Language
- English
- Levels
- MSC
- Frequency
- Yearly recurring
Examination
- Type
- graded semester performance
Course Components
| Type | Title | Time & Place | Hours |
|---|---|---|---|
| lecture with exercise |
Quality Management and Production II
Permission from lecturers required for all students.
Block course (see special program)
Room HCP E47.2
|
No time listed | 16 h semesterly |