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Quality Management and Production II
Last Updated: 2026-02-05 15:40:23
Abstract
The quality and production areas of quality-by-design, continuous manufacturing, life cycle, biotechnology, GMP audits and inspections will be explained in expert detail using examples and case studies.
Objective
The students understand 'Quality Management & Production' in pharmaceutical practice. Following topic related introductory lectures, the students analyze given 'real life' situations to propose a course of action, which is discussed in the light of current practices. 1. Students can analyse advanced quality-by-design cases. 2. Students can discuss continuous manufacturing and quality management during the product's life cycle. 3. Students can describe how to successfully conduct and host audits or inspections of Good Manufacturing Practice (GMP) 4. Students can describe quality issues of biotech drugs.
Content
The following areas will be covered: quality-by-design, continuous manufacturing and quality management during the product's life cycle, GMP audits and inspections, quality issues of biotech drugs.
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
Room HCP E47.2
|
No time listed | 16 h semesterly |