Bild: Image Biotechnologisches Qualitätsmanagement

Biotechnological Quality Management

Curriculum and ECTS

The curriculum provides a detailed overview of the courses, goals, methods, course duration, and course credits.

What is the degree course “worth”? The individual courses are assigned a certain number of credits (30 per semester or 60 per academic year) according to the regulations of the ECTS (European Credit Transfer and Accumulation System), whereby 1 credit represents 25 hours of coursework. A minimum of 180 ECTS credits in total are required for admittance to a Master’s degree programme.

All of the Bachelor’s degree programs offered at FH Campus Wien fulfil the 180 ECTS credits requirement for admittance to a Master’s degree program. Of these 180 ECTS credits, a minimum number must be from a relevant course of study in order to be eligible for admittance to the Master’s Degree Programme for Biotechnological Quality Management. If you have graduated from the Bachelor’s Degree Programmes for Bioengineering, Molecular Biotechnology or Biomedical Analysis, then you have fulfilled this requirement.

This Master’s degree program is worth a further 120 ECTS credits. With the total of 300 ECTS credits that you will have attained after completing this Master’s degree programme, you will be eligible to attend a doctoral programme at the university.

As a biotechnological QM expert from FH Campus Wien, you will be among the first graduates of a university of applied science in Austria who is eligible for admission to the postgraduate course “Pharmaceutical Quality Management” at the University of Vienna. As a trained expert, you will be responsible for the approval of medicinal products.
Following the Master’s degree programme, you may attend a 2-week supplementary course and examination at the Vienna University of Technology to obtain the certificate “Quality Manager”.

 

Programme Type / Times

  • Beginning of studies: begin and end of semester you can find under the option "Organisation of the academic year"
  • You will study part-time.
  • Part-time: on three evenings per week from 18:00 to 21:20, approximately thrice weekly (variable). On Saturdays full-time, approximately every three weeks.
  • Number of weeks of instruction: 20 per semester.

 

ECTS Coordinator

Univ.-Prof. DI Dr. Rudolf Friedrich Bliem
bioengineering@fh-campuswien.ac.at

1. Semester

Course description Contact hours Credits
QM Strategien und Konzepte VO 1,50 3,00
ISO 9001 und GMP VO 3,00 6,00
Computereinsatz und -validierung VO 0,50 2,00
Qualitätskontrolle und Methodenvalidierung VO 1,50 4,00
Qualitätskontrolle Übungen LAB 2,00 4,00
Biotechnologische Verfahren und Produkte VO 1,50 3,00
Pharmakologie VO 1,00 2,00
Toxikologie VO 1,00 2,00
Fermentations- und Enzymtechnologien VO 1,00 2,00
Technische Mikrobiologie VO 1,00 2,00

2. Semester

Course description Contact hours Credits
Validierung VO+UE 2,00 4,00
Technische Prozessanalyse und Validierung VO 1,00 2,00
Risikoanalyse SE 1,00 2,00
Regulatorische Angelegenheiten in der BioT VO 1,00 2,00
Dokumentationswesen VO 1,00 2,00
Umweltmanagement VO 0,50 2,00
Medizinprodukte VO 0,50 1,00
Auditwesen und Gruppenführung VO 1,00 2,00
International Guidance Documents VO 1,00 2,00
Projektarbeit Biotechnologie BVT + QM SE 2,00 5,00
Projektmanagement SE 1,00 1,00
Biotechnologie in Österreich VO 0,50 1,00
Statistische Versuchsplanung VO 1,00 2,00
Biotechnologische Anwendungen in der Medizintechnik VO+UE 1,00 2,00

3. Semester

Course description Contact hours Credits
Projektarbeit Bioverfahrenstechnik BVT + QM SE 2,00 6,00
Biotechnologisches Seminar SE 1,00 5,00
Patentwesen VO 1,00 2,00
Managementtools und MitarbeiterInnenführung SE 1,50 2,00
Risiko und Sicherheit in der Mikrobiologie VO 1,00 2,00
Ausgewählte Kapitel des Rechts VO 1,00 2,00
Betriebshygiene und Sterilisation VO 2,00 4,00
Good Clinical practice VO 1,00 2,00
Design of Experiments VO 1,00 2,00
Entwicklung und Zulassung von Medizinprodukten VO+UE 1,00 3,00

4. Semester

Course description Contact hours Credits
Diplomarbeit DA 0,00 23,00
Diplomarbeitsbetreuung DA 4,00 6,00
Diplomandinnen- und Diplomandenseminar SE 1,00 1,00
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