Quality management in the strict context of Good Manufacturing Practice is a legal requirement in particular for the biopharmaceutical industry. The necessary management optimization also opens up a wide range of opportunities. The degree program provides both. Biotechnological Quality Management combines technical expertise with management methods. The degree program focuses on quality management for biotechnological processes and products including Good Manufacturing Practice. As a graduate, you will develop and realize customer-oriented products and improve the company-internal process quality.
Elisabeth BeckElisabeth Holzmann, Bakk.techn.Johanna BauerBarbara PhilippMuthgasse 621190 ViennaT: +43 1 606 68 77-3600F: +43 1 606 68 email@example.com
Map Muthgasse (Google Maps)
Office hours during semesterMon to Thu, 4.30 p.m.-6.00 p.m.
By appointmentMon to Thu, 10.00 a.m.-6.00 p.m.Fri, 10.00 a.m.-1.00 p.m.
Application period for academic year 2022/23
1st January to 15th June 2022
tuition fee / semester:
+ ÖH premium + contribution2
1 Tuition fees for students from third countries € 727,- per semester
2 for additional study expenses (currently up to € 83,- depending on degree program and year)
You have basic know-how in natural sciences, process engineering and quality management. In addition, you have an above-average risk-benefit awareness and are an analytical and process-oriented thinker. You enjoy working on projects in a team and would like to take on management responsibilities. Average English skills are expected. Language of instruction is German
Your education and research benefit from our close partnerships with the University of Natural Resources and Life Sciences, Vienna (BOKU) and the associated Vienna Institute of Biotechnology (VIBT), who share the campus with us, as well as our strong network in the industry. You will learn from experts from biotech companies that play a leading role when it comes to combining Good Manufacturing Practice-oriented quality management with management methods. Practical relevance is also guaranteed at our Campus Lecture evenings, which are open to all and feature contributions from prominent experts.Once you have completed the bachelor's degree program in Bioengineering and the master's degree program in Biotechnological Quality Management, you will be entitled to attend the postgraduate course "Pharmaceutical Quality Management" at the University of Vienna and thus in the future be responsible for the approval of medicinal products. For further information, please visit the secretary's office.
Good Manufacturing Practice is required in the biopharmaceutical and other industry sectors, and management optimization is the means to implement it.The degree program provides both.While certain regulatory conditions in the biopharmaceutical industry are legally binding and leave little room for economic considerations, companies are focusing more and more on processes that can be optimized and therefore can be carried out more cost-effectively.Management methods such as value stream analysis, operations research or energy-related evaluation are necessary tools when business decisions must be made.With this management know-how, you will be highly sought after.
This program will provide you with extensive QM expertise.
Lector: Dr. Reinhard Preiss
Application of specialized techniques for risk analyses: Fault Tree Analysis Event Tree Analyses and Layer of Protection Analysis HACCP SWIFT (Structured What-If) Analyses; Checklists
written exam (risk analysis examples)
Presentation of techniques, common acquirement of working examples.
Lector: O.Univ.-Prof. Mag.pharm. Dr. Helmut Viernstein
The course addresses the technology of manufacturing formulations for the parenteral application as well as methods of quality control according to the rules of the European and international pharmacopeia. In this context, well established formulations and innovative products will be presented and special biopharmaceutical aspects will be discussed.
Basic considerations of Risk Management; Terminology in the field of risk analysis; Typical fields of application and legal aspects; Process safety incidents; Risk assessment (qualitativ, quantitive, semi-quantitative); Analysis methodologies: FMEA HAZOP FMEA HAZOP Fault-Tree-Analysis (Basics)
Presentation, common acquirement of working examples.
Lector: Dr. MMag. Agnes Bugajska-Schretter, DI (FH) DI Dr. Juan Antonio Hernandez Bort
This course mainly presents biological and biotechnological manufactured products with the focus on application of innovative drugs (monoclonal antibodies, vaccines, gene therapy and cellular therapies) without overlooking the importance of plasma-derived products. Fundamentals of drug development also from a regulatory and economic point of view, including clinical development and the associated challenges and aspects of tolerability and effectiveness in selected diseases (including so-called orphan diseases) are discussed. The aim is to gain an understanding of “patient-tailored” approaches compared with historical, less unspecific treatments using examples from oncology. With in-depth examples of individual innovative therapeutic agents such as AAV9-based gene therapy, immune checkpoint inhibitors for tumor diseases and others, a holistic view is to be given from the perspective of developers and manufacturers on the one hand, but also patients. Basics of genetics and immunology with regard to their application in the context of modern, biological therapeutic approaches and vaccines are outlined. The relevance for practical use is considered from an economic, medical point of view, but also from the point of view of the health system payers (key players in the biotech industry, vaccination programs, biotech companies, licensing authorities, etc.). An outlook for activities in the biotech and pharmaceutical industry is given.
Lector: Hon.-Prof. Univ.-Doz. DI Dr. Rudolf Friedrich Bliem
Terms, principles, concepts and practice of today´s Quality Management and in particular of good manufacturing practice; processes and operating procedures, manufacturing documents; models and Standards; the concept of error and its general relevance; GMP: legal Framework and purpose; selected subjects and aspects of GMP.
Written exam + practical exercise
Lecture with discussion Homework
Lector: Frank Kasteliz
Good manufacturing practices of the European Commission (EUDRALEX The Rules Governing Medicinal Products in the European Union) provide minimum requirements that a pharmaceutical product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public. Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that drug product is safe for human consumption.
Written examination (open book exam) at the end of course.
PowerPoint presentation of the content, reading/exertion of the EUDRALEX documents; teamwork and workgroups to learn and understand the most topics in the pharmaceutical industry.
Lector: DI Dr. nat. techn. Matthias Hackl, Dipl.-Ing. Dr. Michael Traxlmayr
The first part (Dr. Hackl) gives an overview of the human immune system with a focus on the tissues and cells that are involved: lymphoid and myeloid cells and their functions. Diseases related to the immune system (e.g. infectious diseases, allergies and autoimmune disorders) will be discussed, as well as the application of T-cells and dendritic cells in cancer therapy. Finally, we will discuss the biology of the B-cell and how the huge diversity of antibodies in the human immune system is generated. In the second part (Dr. Traxlmayr) the great biopharmaceutical potential of antibodies will be discussed: the structure and biological function of antibodies; methods for the biochemical characterization of antibodies; methods for antibody selection in the drug development process, as well as engineering strategies for optimization of antibodies and antibody fragments for therapeutic purposes (e.g. bispecific antibodies). Finally we will cover different processes for manufacturing poly- and monoclonal antibodies and medical applications, such as cancer therapy and treatments of autoimmune disorders.
The assessment will be based on a presentation of a scientific publication. The publication, which should be related to immunology, can either be proposed by the student or chosen from a list that was pre-selected by the lecturers. After the 12-minute presentation lecturers and students will ask questions related to the presented publication and the theoretical background. The grade will be based on both the presentation and the discussion after the presentation. The publications can be presented in groups of 2 persons at most.
Lecture/presentation of theoretical background knowledge on immunology will be combined with practical examples from industry, as well as short questions and problem solving sessions during the lecture.
Lector: Horia-Paul Bunduc, BSc, Ing. DI (FH) Dr. Harald Kühnel, MSc, Katharina Seiberl, BSc MSc
Implementing an analytical method to practice the validation of analytical methods in depth
interactive participation Assessment of practical work and authoring of all validation documents
Lector: Georg Hochfellner, BSc MSc
- Fundamentals, context and definitions of quality management - The ISO 900ff family of standards at a glance - Standard requirements of EN ISO 9001:2015 in detail
- written exam
- Lecture and exercises
Lector: Mag. Dr. Oliver Kudlacek, DI Dr. Herwig Moll
Basics of Physiology; Cellcycle, immunology, metabolic processes, signal transduction, blood system, heart, autonomous nervous system, central nervous system, receptors and ion-channles
Lector: DI(FH) Robert Schwarz
The course covers the foundation of validation, regulatory requirements and guidelines, equipment qualification (DQ, IQ, OQ, PQ), risk analysis, method validation, process validation, cleaning validation and sterilization/sanitization validation. Focusing of the preparation of associated documentation through validation projects will be included in practical detail.
Concurrent performance assessment via blended learning tasks and permanent review of content already bespoken incl. solving examples to demonstrate the ability to apply the content practically. If after the last lesson before the written final exam (or the final due date for the BL excercises) less than 60 % of the required performance were provided in addition, following directly the written final exam an oral examination has to be performed. This will be communicated the students affected in an appropriate manner (via Moodle, by mail). 1st test date: Written final exam (multiple choice, formulated questions and calculation examples). Generally, further dates (not exam attempts!) are conducted as oral exams. The test modality will be announced with the test date. Weighting of the final grade: Final Exam 60% and blended learning tasks 40% (each part must be completed with a positive grade)
Lecture (as distance learning via Zoom) and blended learning The lecture slides and additionally the comments of the lecturer during the lecture are the basis of the course content. Those will be additionally completed with the content (documents, videos, podcasts, internet links, ...) for the blended learning tasks. The sum of this all is relevant for the blended learning tasks (i.e. permanent progress check) and the written final exam.
Lector: Ing. Mag.(FH) Wolfgang Pölz, MSc, MBA
Creation and, to a limited extent, the implementation of a quality management system. Furthermore, this course is oriented towards the subsequent LV external and internal audit.
Active cooperation, written and oral examination at the end of the course "auditing", which also includes the course "external and internal auditing" and "development of the QMS".
Seminaristic work, theoretical impulses
Lecture and exercises. The Focus lies on Independent Problem solving.
Lector: Hon.-Prof. Univ.-Doz. DI Dr. Rudolf Friedrich Bliem, Dipl.-Ing. Gerald Holzmann, Bakk. techn., Dr. Roman Käfer
Extending and deepening the contents of the course "Einführungen in GMP und Qualitätsmanagement" varied lectured and practical coursework.
Lecture, discussion, practical
The requirements for planning and carrying out system and process audits are learned within the framework of this course. This course forms the theoretical preparation for the following course "Auditing exercise".
Active Cooperation, written and oral examination at the end of the course "auditing", which also includes the course "External and internal auditing" and "development of the QMS"
seminaristic work, theoretical impulses
Lector: Dr. Ing. Christoph Kogler, MSc. BSc.
This course provides a hands-on introduction to processes modeling (Module 1: BPM, Module 2: BPR) and simulation (Module 3: DES, Module 4: ABS). Application examples, case studies and tutorials are implemented, analyzed and interpreted in the Bee-Up and AnyLogic software packages. Structure: 1st module: Business Process Modeling (BPM) 2nd module: Business Process Reengineering (BPR). 3rd module: Discrete Event Simulation (DES) 4th module: Agent-based Simulation (ABS) and System Dynamics (SD)
Collaboration, tasks, tests, challenges, group work, presentations, practice examples
Lecture, surveys, presentation and discussion in online sessions. Literature study and assigements in self-study modules.
Lector: Eva Valerie Lehner, BSc, Dipl.-Ing. Dr. Alexandra Posekany
General topics of statistics: exploratory data analysis basics of statistical inference (hypothesis testing) statistical modeling, selection of models, logistic regression
homework exercises and oral final examination with presentation
Applied practice with "R"
Basics of pharmacology and toxicology
written exam with multiple choice and open questions
Lector: Mag. Wolfgang Kreiter
The lecture "Foundations of Operations Research" - gives an insight into the foundations and problem definition of Operations Research - deals with selected procedures such as linear programming and combinative optimization by detailed description of the approach and the practicing of simple examples - explains further OR-produres such as queuing theory, game theory and simulation as preparation for the lectures: 1) optimization problems and 2) simulation models and application - gives an impression of the stochastic generally and the probability theorie particularly
The assessment of the lecture: Written exam (100% of the points) Additions points can be gained by the students for their collaboration e.g. by calculating practical exercises
The lecture "Foundations of Operations Research" is planned to be a combination of theoretical lecture and the praticing of examples. The students can use lecture notes from which the trainer presents the slides via beamer. In addition to that the students get an Excelfile for practising the Simplex algorithm. Moreover the lecture contains the practising of examples on the blackboard by the students or the lecturer in the unit which follows the preceding lecture The last unit is planned for the final written test.
Lector: Dipl.-Ing. Gerald Holzmann, Bakk. techn.
Solving optimization problems using XPress.
Practices and final exam.
- lecture - practice - examples
Lector: Mag. Theresa Balber, Mag. Dr. Cecile Philippe, Andreas Schirmbrand, Assoc.Prof. Priv.Doz. Mag. Dr. Stefan Tögel, O.Univ.-Prof. Mag.pharm. Dr. Helmut Viernstein
The course comprises the manufacturing of well established application forms, e.g. granules, pellets, tablets, capsules or parenterals and inhalants as well as the production and development of innovative products. In addition, biopharmaceutical aspects of the enhancement of efficacy of drugs will be discussed. A main topic of the practical course is the quality control according to the rules of the European Pharmacopoeia.
lecture and practical course
Lector: Mag. Katharina Raab-Kashofer
Legal requirements for food in the context of European and national legislation Requirements from currently applicable food standards (IFS etc.) Requirements for GHP (Good Hygiene Practice) in food production in accordance with applicable standards Basics of implementing a HACCP system Practical exercises for the implementation and evaluation of a QM system in food production
introduction and examination (presence modules) working in groups and private studies (distance learning) presentation of results (group work) incl. discussion (ZOOM presentation)
Lector: Ing. Gerald Berger
See German description
Lector: Dipl.-Ing. Dr. Alexandra Posekany
General topics of statistics: exploratory data analysis basics of statistical inference statistical modeling, selection of models, logistic regression
Homework, in class Participation, final examination
• Definitions of errors • Reasons for errors in the person, in the system, in the organisation • Coping with criticism • Exercises in the communication of mistakes
Continous assessments throughout the course
Lector: Dr. Roman Käfer, Ing. Mag.(FH) Wolfgang Pölz, MSc, MBA
Within the scope of this course, the planning and execution of system and process audits are practiced. The QM system elements and process descriptions of previous courses are to be used at least partially for this purpose.
Lector: Dr. Robert Leubolt
- Terms and definitions - Principles of auditing - Managing of audit programms - Audit activities - Competence and evaluation of auditors - Task of Lead assessors - Practical audits - Systems in the area of conformity assessments
- written examination at the end of the course
- Seminar - individuell work on specific examples in the area of auditing
Good Manufacturing Practice (GMP) forms a quality framework for the production of pharmaceutical and biotechnological products. Plant Hygiene represents a central pillar of GMP, both in the way of general principles for avoiding adventious product contamination and through specific forms of implementation and instruments.
Concurrent performance assessment via permanent review of content already bespoken incl. solving examples to demonstrate the ability to apply the content practically. 1st test date: Written final exam (multiple choice, formulated questions and calculation examples). Generally, further dates (not exam attempts!) are conducted as oral exams. The test modality will be announced with the test date. Weighting of the final grade: Final Exam 100%; blended learning tasks (in principle voluntary; can improve the overall grade, but cannot compensate a negative exam grade)
Lecture (WS21/22 as distance learning via Zoom) and blended learning The lecture slides and additionally the comments of the lecturer during the lecture are the basis of the course content. Those will be additionally completed with the content (documents, videos, podcasts, internet links, ...) for the blended learning tasks. The sum of this all is relevant for the final exam.
This course willl convey concepts of biological safety, as defined by occupational and health requirements, and biological security. In this context it will include a discussion on assessment critieria for biological safety and present the biological risk Groups. This will be followed by a discusion of the technical measures as defined by the risk classes. This will complete with a brief view into further aspects of biosafety and a personal work report as medical laboratory analyst in the recent Ebola epidemic in africa.
Lector: Mag. Dipl.-Ing. Dr. Martin Pfeffer, Mag. Karin Pfeffer
"hands-on" priciples in business administration Development of a business plan
preparation & presentation of a business plan
Lector: Dipl.-Ing. Barbara Lederer
Basic concepts of Data Mining Introduction into Visualization Pros and Cons in representations Practical exercises
The examination consists of attendance, active participation as well as the grading of exercise work and presentations.
Lecture plus exercise
Lector: Univ.-Prof. DI Dr. Herbert Braun
Fundamentals of energy engineering, conservation of energy, exergy and anergy, operating figures, calkulation of energy flow. Energy flow in Austria: primary and final energy, sources of energy, grids and heating circles. Different types of energy: conventional and renewable energy. Hot water and steam boilers. Energy flow in industry (with eamples)
Lector: Mag. DDr. Alexander Hönel, MSc MBA LLM
To gain the essential know how on the topic clinical trial and clinical studies. Insight into the legal basis for these kinds of experiments and their positioning in the life cycle of the product. Which phases of clinical trials do exist? What are the risks? Quality control and quality assurance as well as actual changes in the legal environment.
Presentation of the student and their evaluation as assessment
Introduction into the topic as lecture, followed by selected topics to be presented by the student on the last day of the lecture.
Lector: FH-Prof. DI Dr. Michael Maurer, Dipl.Ing. Dr. Christine Prenner, Ao.Univ. Prof. DI Dr. Karola Vorauer-Uhl
This course is focused on Quality Assurance and Quality control aspects and strategies. Both GMP and ISO/IEC 17025 systems will be introduced. Therefore, general rules but also similarities and differences will be addressed. The dynamic development in both systems and their consequences will be discussed accordingly.
30% presentation 30% homework 40% final, written examination each part need to be positive
The course has been established as an interactive workshop subdivided into a homework part and an attendance part. For the work at home general documents and specific documents for the presentations are presented on the moodle platform. The individual presentations, discussion and selected examples will be done in the attendance time. Further and more detailed instruction are given on the moodle plattform
Lector: Mag. Dr. Elke Litzlbauer, DI (FH) Jürgen Waditschatka, DI Dr. Christa Wirthumer-Hoche
This lecture gives a broad overview of the regulatory requirements for licensure of biological/ biotech products. The main pharmaceutical aspects in regard of compliance will be practical elaborated.
written assignment of the respective task including verbal presentation / questioning
Lecture / Tutorial
Lector: Dr. Moritz Imendörffer
Regulatory expectations on statistical process control (SPC) in the pharmaceutical industry, statistical process models, measures of central tendency and dispersion of discrete and continuous distributions, elementary tools of SPC
lecture with excercises
Lector: Mag. Dr. Andreas Franz
ISO 14001, EMAS-VO including interpretation of the standards Identification and evaluation of environmetal aspacts and associated impacts management of applicable legal requirements environmetal objectives, targets and programme(s) emergency perpardness and response internal audits (only overview) internal and external communication, environmetal statement
written exam Presentation of a group work on a given topic
Lecture with the help of slides, added with practical examples
Terms and overview of processes for microbial inactivation Processes of moist heat inactivation, as well as chemical and thermal disinfection Predictive calculation models
This lecture teaches the management of safety and health at work according to ISO 45001:2018, with guidance on the practical application of the standard points, which are deepened by means of examples. Occupational health and safety in connection with sustainability considerations in companies. What is the "Return on Prevention"? Differences to OHSAS 18001:2007 Legal basis in Austria
Written examination, presentation if necessary, online examinations if necessary in accordance with the hygienic requirements.
Lecture, group work with presentation according to the possibilities (presence phase, online phase)
Lector: FH-Prof. DI Dr. Michael Maurer
Preparation for the master´s degree examination
Presentation with assessment of the master´s degree thesis and general examination
The content of this course is the writing of a diploma thesis.
The "written diploma thesis" constitutes the result of the quality of the works conducted. For this reason, the assessment is based on the quality of the research as well as on the written presentation.
The diploma thesis has to be written in consultation with the FH supervisor and beforehand has to be approved by the head of the academic section.
Lector: Ing. DI (FH) Dr. Harald Kühnel, MSc, FH-Prof. DI Dr. Michael Maurer
In this class each student has to give a scientific presentation of his or her diploma thesis as preparation for the diploma examination - What has to be considered when presenting scientific work? - Give and receive feedback.
Assessment of the given presentation (structure, slide deck, presentation style, timing).
Semester dates Winter semester: Mid of August to end of January Summer semester: Beginning of February to mid of July
Number of teaching weeks 20 per semester
Times 6.00 p.m. to 9.20 p.m. (ca. four times from Mon to Fri), Sat ca every two weeks from at 8:30 a.m. (allday)
Language of instruction German
As a QM expert you will be qualified to take on responsibility in quality assurance, quality control or validation in the product registration, plant design, auditing and GMP fields. You will find a career in the following occupational fields:
Regulation for the admission of third country citizens (PDF 233 KB)
Information for applicants with non-Austrian (school) certificates (PDF 145 KB)
There are 18 places available in the master's degree program in Biotechnology Quality Management each year. The ratio of places to applicants is currently around 1:3.
To apply you will require the following documents:
Please note: It is not possible to save incomplete online applications. You must complete your application in one session. Your application will be valid as soon as you upload all of the required documents and certificates. In the event that some documents (e.g. references) are not available at the time you apply, you may submit these later via email, mail or in person by no later than the start of the degree program.
The admission procedure consists of a written test and an interview with the admission committee.
The study places are awarded at the latest in mid-July based on this ranking. The process as a whole and all test and assessment results from the admission procedure are documented in a transparent and verifiable manner.
Written test and interview May and June
Planned start of the first semester Mid of August
Head of Degree Program Bioengineering, Bioinformatics, Biotechnological Quality Management, Bioprocess Engineering T: +43 1 606 68 firstname.lastname@example.org
New study location from winter semester 2022/23 The Department of Applied Life Sciences will move to the new building at Favoritenstraße 222, 1100 Vienna in the summer of 2022.
We work closely with numerous industrial companies, universities such as the University of Natural Resources and Life Sciences, Vienna (BOKU), the Austrian Centre of Industrial Biotechnology (ACIB) and other research institutes. This guarantees you strong contacts for internships, employment or participation in research and development activities. You can find information about our cooperation activities and much more at Campusnetzwerk. It's well worth visiting the site as it may direct you to a new job or interesting event held by our cooperation partners!
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Information Biotechnological Quality Management Master (PDF 91 KB)
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