790353 Quality management in biotechnology (in Eng.)

Vorlesung und Übung
Vortragende/r (Mitwirkende/r)
Vorauer-Uhl, Karola , Prenner, Christine
Angeboten im Semester
Wintersemester 2023/24
Unterrichts-/ Lehrsprachen


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

Inhaltliche Voraussetzungen (erwartete Kenntnisse)

General knowledge of Quality Management and application


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.
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