790353 Quality management in biotechnology

Lecture and exercise
Semester hours
Lecturer (assistant)
Vorauer-Uhl, Karola , Prenner, Christine
Offered in
Sommersemester 2024
Languages of instruction


International GMP guidelines
Selected chapters of the GMP / Vol4
Responsibilities of the national Agencies (AGES)
PIC/S Guidelines and Aide Memoires
ICH-Concept a selected topics
The Pharmacopoeia
Quality management and Good Documentation Practise
Batch Certification and Qualified Person
Risk Management
Qualification and Validation
Audits and Inspections
Further development in GMP regulations

Previous knowledge expected

General knowledge of Quality Management an application

Objective (expected results of study and acquired competences)

Within the workshop each student will present a defined topic, followed by related exercises. Finally, a group work is performed to apply general GMP aspects. After this course students will be familiar with the GMP concept and its general applicability for the manufacturing of medicinal products. They will be able to navigate within the GMP system and to correctly apply all regulatories in quality management.
You can find more details like the schedule or information about exams on the course-page in BOKUonline.