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 firstname.lastname@example.org
Office hours:Mon. to Thu. 4:00 p.m. to 6:00 p.m.
By appointmentMon. to Thu. 10:00 a.m. to 6:00 p.m.Fri. 10:00 a.m. to 1:00 p.m.
Application period for academic year 2019/20
1st January 2019 to 15th June 2019
tuition fee / semester:
+ ÖH premium + contribution**
* Tuition fees for students from third countries € 727 per semester
**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. MMag. Agnes Bugajska-Schretter, Dipl.-Ing. Helga Sgardelli, Dr. Martin Spruth
This course will introduce biological and biotechnological manufactured products with the focus on medicinal products (blood products, vaccines, recombinant proteins, monoclonal antibodies, biosimilars). Basic considerations on technological processes and manufacturing methods as well as analytical methods and considerations of viral safety will be presented. Genetic and immunological principles in the context of modern, biological medicinal therapies will be reviewed. Practical approaches for utilization of the products and for working in the biotech environment will be highlighted (key player in the biotech industry, vaccination programs, biotech company, license).
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 discussionHomework
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.
Writtenexamination 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: DI(FH) Robert Schwarz, Brigitta Schwarz, Mag. Helga Weisse
Implementing an analytical method to practice the validation of analytical methods in depth
interactive participationAssessment 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: 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.
Lector: Mag. Dr. Oliver Kudlacek, Priv.Doz.in Dr.in Dagmar Stoiber-Sakaguchi
Basics of Physiology; Cellcycle, immunology, metabolic processes, signal transduction, blood system, heart, autonomous nervous system, central nervous system, receptors and ion-channles
Lector: Dr. Reinhard Preiss
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: DI(FH) Robert Schwarz, Brigitta 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 for active participation and permanent review to content already bespoken incl. solving examples to demonstrate the ability to apply the content practically.If at the end of the last lesson before the written test less than 60 % of the required performance were provided in addition, following the written test an oral examination has to be undergone. This will be communicated the students affected in an appropriate manner (in person, by mail).Written Exam (multiple choice, text questions and sample calculations)Weighting of the final grade: Written Exam 50%, active participation 20% and documents 30% (each part must be completed with a positive grade)
Lecture, discussions and examplesThe lecture slides and additionally the comments of the lecturer during the lecture are the basis of the course content.The sum of this all is relevant for the permanent review and the written test.
Application of specialized techniques for risk analyses:Fault Tree AnalysisEvent Tree Analyses and Layer of Protection AnalysisHACCPSWIFT (Structured What-If) Analyses; Checklists
written exam (risk analysis examples)
Presentation of techniques, common acquirement of working examples.
Lector: Dr. Martin Hofer, MSc MBA
Role of natural IgM antibodies in immune surveillanceStructure and function of natural IgM antibodiesManufacturing platforms for IgM antibodies Quality management of natural IgMs? why are natural IgM antibodies not in use for immuno-therapeutic applications ?
Lecture and exercises. The focus lies on independent problem solving.
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 lectureThe 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: Dr. Christian Fikar, MSc, Dipl.-Ing. Martin Pernkopf, BSc
This course teaches simulation models and applications. The focus is set on the development of small-scale simulation models and the critical interpretation of results.
3 group assigments (15% each)In-class participation (15%)Final exam (40%)
LectureGroup WorkHands-on experience with the simulation software 'AnyLogic'
legal national and European food requirementsexigences concerning implementation of Good Hygiene Praxis in food industryKnowledge base concerning HAACPpractical exercises concerning validation and implementation of a quality system in food production
Lector: Ing. Gerald Berger
See German description
Lector: Dipl.-Ing. Dr. Alexandra Posekany
General topics of statistics:exploratory data analysisbasics of statistical inferencestatistical modeling, selection of modelsgeneralized models (logistic regression)
Participation, final examination
Applied practice with "R"
Lector: Dipl.-Ing. Dr. Alexandra Posekany, MMag. Sin-Yeung Yoo
continous assessments throughout the course and 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. 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
Lector: DI(FH) Robert Schwarz
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.
Written Exam and participation during lectures
lectured course and participation
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 administrationDevelopment of a business plan
preparation & presentation of a business plan
Lector: Dipl.-Ing. Barbara Lederer
Basic concepts of Data MiningIntroduction into VisualizationPros and Cons in representationsPractical exercises
The examination consists of attendance, active participation as well as the grading of the exercisework.
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: Dipl.Ing. Dr. Christine Prenner, Prof. 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% presentation30% groupwork40% final, written examinationeach 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: 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 will be practical elaborated.
written assignment of the respective task including verbal presentation / questioning
Lecture / Tutorial
Lector: Dipl.-Ing. Florian Jantscher, PhD
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
Terms and overview of processes for microbial inactivationProcesses of moist heat inactivation, as well as chemical and thermal disinfectionPredictive calculation models
Lector: Mag. Dr. Andreas Franz
ISO 14001, EMAS-VO including interpretation of the standardsIdentification and evaluation of environmetal aspacts and associated impactsmanagement of applicable legal requirementsenvironmetal objectives, targets and programme(s)emergency perpardness and responseinternal audits (only overview)internal and external communication, environmetal statement
Lecture with the help of slides, added with practical examples
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: Dipl.-Ing. Dr. Johanna Hämmerle
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 datesSummer semester 2019: 11th February to 12th July 2019Winter semester 2019/20: 19th August 2019 to 1st February 2020
Number of teaching weeks20 per semester
Times6:00 p.m. to 9:20 p.m. (ca. three times from Mon to Fri), Sat ca every two weeks from at 8:30 a.m. (allday)
Language of instructionGerman
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:
With at least > 60 ECTS credits in natural sciences (chemistry, microbiology, mathematics, statistics, biochemistry, molecular biology) and > 13 ECTS credits in technical subjects (process engineering, principals of bioprocess technology, measurement and control technology). > Quality management and technical law. More information is available upon request.
Equivalence is determined by international agreements, validation or in individual cases a decision by the head of the academic section.
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 1:1,5.
To apply you will require the following documents:
Certificates from abroad as well as a description of the courses and exemplary documents must be submitted as certified translations. Letters of recommendation from teachers from the institute abroad will help the head of the academic section to assess whether the admission requirements have been fulfilled.
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 selection process consists of a written test and an interview with the selection committee.
Head of Degree Program Bioengineering, Bioinformatics, Biotechnological Quality Management, Bioprocess Engineering T: +43 1 606 68 77-3601 email@example.com
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.
Head of Degree Program Bioengineering, Bioinformatics, Biotechnological Quality Management, Bioprocess Engineering
We work closely with numerous industrial companies, universities such as the University of Natural Resources and Life Sciences, Vienna (BOKU) and other research institutes. This guarantees you strong contacts for your professional career 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!