Biotechnological Quality Management

Overview

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.

Contact us!

Elisabeth Beck
Elisabeth Holzmann, Bakk.techn.
Johanna Bauer
Barbara Philipp
Muthgasse 62
1190 Vienna
T: +43 1 606 68 77-3600
F: +43 1 606 68 77-3609
bioengineering@fh-campuswien.ac.at

Map Muthgasse (Google Maps)

Office hours during semester
Mon to Thu, 4.30 p.m.-6.00 p.m.

By appointment
Mon to Thu, 10.00 a.m.-6.00 p.m.
Fri, 10.00 a.m.-1.00 p.m.

Duration of course: 4 Semester

Final degree: Master of Science in Engineering (MSc)

18Study places

120ECTS

Organisational form: part-time

Application period for academic year 2020/21

1^st January to 15^th June 2020

tuition fee / semester:

€ 363,36¹

+ ÖH premium + contribution²

¹ Tuition fees for students from third countries € 727,- per semester

²for additional study expenses
(currently up to € 83,- depending on degree program and year)

What you can offer

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

What we offer you

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.

What makes this degree program special

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.

Woman in white coat fills out list on red clipboard and a young man in white coat working on machine in the front

What you will learn in the degree program

This program will provide you with extensive QM expertise.

In the field of quality management you will learn about a wide variety of norms and regulations: ISO 9001, Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP). You will acquire know-how in company hygiene, risk and safety in microbiology, process analysis and validation, quality control, and products and their production.
You will expand your knowledge of bioprocess technology, pharmacology and toxicology.
You will study the legal foundations that set the essential standards for quality management. This will also include international guidance documents, documentation and patent law.
You will acquire the principles of planning and development including project management and corporate management as well as methods for scientific work.

Curriculum

1. Semester

Lecture	SWS	ECTS
Technical Risk Analysis Practice UE Technical Risk Analysis Practice UE Lector: Dr. Reinhard Preiss 1SWS 2ECTS Lecture contents 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 Assessment methods written exam (risk analysis examples) Teaching methods Presentation of techniques, common acquirement of working examples. Language German	1	2
Parenterals VO Parenterals VO Lector: O.Univ.-Prof. Mag.pharm. Dr. Helmut Viernstein 1SWS 2ECTS Lecture contents 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. Assessment methods written examination Teaching methods lecture	1	2
Technical Risk Analysis ILV Technical Risk Analysis ILV Lector: Dr. Reinhard Preiss 1SWS 2ECTS Lecture contents 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) Assessment methods written exam Teaching methods Presentation, common acquirement of working examples. Language German	1	2
Bioprocesses and Products VO Bioprocesses and Products VO Lector: Dr. MMag. Agnes Bugajska-Schretter, Dipl.-Ing. Helga Sgardelli, Dr. Martin Spruth 1.5SWS 3ECTS Lecture contents 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). Assessment methods Final Exam Teaching methods Lecture Language German	1.5	3
Introduction to GMP and Quality Management VO Introduction to GMP and Quality Management VO Lector: Hon.-Prof. Univ.-Doz. DI Dr. Rudolf Friedrich Bliem 1SWS 2ECTS Lecture contents 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. Assessment methods Written exam + practical exercise Teaching methods Lecture with discussion Homework Language German	1	2
Good Manufacturing Practice, Eudralex ILV Good Manufacturing Practice, Eudralex ILV Lector: Frank Kasteliz 1SWS 2ECTS Lecture contents 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. Assessment methods Written examination (open book exam) at the end of course. Teaching methods 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. Language German	1	2
Immunology VO Immunology VO Lector: DI Dr. nat. techn. Matthias Hackl, Dipl.-Ing. Dr. Michael Traxlmayr 1SWS 2ECTS Lecture contents 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. Assessment methods 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. Teaching methods 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. Language German-English	1	2
Implementation of Analytical Methods UE Implementation of Analytical Methods UE Lector: DI(FH) Robert Schwarz, Mag. Helga Weisse 1.5SWS 2ECTS Lecture contents Implementing an analytical method to practice the validation of analytical methods in depth Assessment methods interactive participation Assessment of practical work and authoring of all validation documents Teaching methods Lectured practical Language German	1.5	2
ISO 9001 ILV ISO 9001 ILV Lector: Georg Hochfellner, BSc MSc 1.5SWS 3ECTS Lecture contents - 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 Assessment methods - written exam Teaching methods - Lecture and exercises Language German	1.5	3
Physiology VO Physiology VO Lector: Mag. Dr. Oliver Kudlacek, DI Dr. Herwig Moll 1SWS 2ECTS Lecture contents Basics of Physiology; Cellcycle, immunology, metabolic processes, signal transduction, blood system, heart, autonomous nervous system, central nervous system, receptors and ion-channles Assessment methods written exam Teaching methods Lecture Language German	1	2
Validation ILV Validation ILV Lector: DI(FH) Robert Schwarz 1SWS 2ECTS Lecture contents 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. Assessment methods 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 60% and active participation 40% (each part must be completed with a positive grade) Teaching methods Lecture, discussions and examples The 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. Language German-English	1	2
QM-System Development ILV QM-System Development ILV Lector: Ing. Mag.(FH) Wolfgang Pölz, MSc, MBA 1SWS 2ECTS Lecture contents 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. Assessment methods 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". Teaching methods Seminaristic work, theoretical impulses Language German	1	2
Selected Subjects in Quality Management and Master Thesis Preparation SE Selected Subjects in Quality Management and Master Thesis Preparation SE Lector: Ing. Mag.(FH) Wolfgang Pölz, MSc, MBA 1SWS 2ECTS Lecture contents . Assessment methods Course immanent Teaching methods Lecture and exercises. The Focus lies on Independent Problem solving.	1	2
Selected topics in Quality Management VO Selected topics in Quality Management VO Lector: Hon.-Prof. Univ.-Doz. DI Dr. Rudolf Friedrich Bliem, Dipl.-Ing. Gerald Holzmann, Bakk. techn. 1SWS 2ECTS	1	2

2. Semester

Lecture	SWS	ECTS
External and internal auditing VO	0.5	1
Process Modelling and Simulation VO+UE Process Modelling and Simulation VO+UE Lector: Ing. Christoph Kogler, BSc MSc, Dipl.-Ing. Martin Pernkopf, BSc 2.5SWS 5ECTS Lecture contents 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. Assessment methods 3 group assigments (15% each) In-class participation (15%) Final exam (40%) Teaching methods Lecture Group Work Hands-on experience with the simulation software 'AnyLogic'	2.5	5
Specific Statistics Practice UE Specific Statistics Practice UE Lector: Eva Valerie Lehner, BSc, Dipl.-Ing. Dr. Alexandra Posekany 1SWS 2ECTS Lecture contents General topics of statistics: exploratory data analysis basics of statistical inference (hypothesis testing) statistical modeling, selection of models, logistic regression Assessment methods homework exercises and oral final examination with presentation Teaching methods Applied practice with "R" Language German	1	2
Biopharmakology VO Biopharmakology VO Lector: Mag. Dr. Oliver Kudlacek, Priv.Doz.in Dr.in Dagmar Stoiber-Sakaguchi 1.5SWS 3ECTS Lecture contents Basics of pharmacology and toxicology Assessment methods written exam with multiple choice and open questions Teaching methods Lecture Language German	1.5	3
Introduction to Operations Research VO Introduction to Operations Research VO Lector: Mag. Wolfgang Kreiter 1SWS 2ECTS Lecture contents 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 Assessment methods 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 Teaching methods 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. Language German	1	2
Optimization Methods UE Optimization Methods UE Lector: Dipl.-Ing. Gerald Holzmann, Bakk. techn. 1SWS 2ECTS Lecture contents Solving optimization problems using XPress. Assessment methods Practices and final exam. Teaching methods - lecture - practice - examples Language German	1	2
Pharmaceutical Technology VO+UE Pharmaceutical Technology VO+UE 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 2SWS 4ECTS Lecture contents 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. Assessment methods written examination Teaching methods lecture and practical course Language German	2	4
QM in Food Production VO QM in Food Production VO Lector: Dr. Martin Hofer, MSc MBA 1SWS 2ECTS Lecture contents legal national and European food requirements exigences concerning implementation of Good Hygiene Praxis in food industry Knowledge base concerning HAACP practical exercises concerning validation and implementation of a quality system in food production Assessment methods written examination Teaching methods lecture/group work/discussion Language German	1	2
Six Sigma, Lean, Kaizen VO+UE Six Sigma, Lean, Kaizen VO+UE Lector: Ing. Gerald Berger 2SWS 4ECTS Lecture contents See German description Assessment methods Exam Teaching methods See German description Language German	2	4
Specific Statistics VO+UE Specific Statistics VO+UE Lector: Dipl.-Ing. Dr. Alexandra Posekany 1SWS 2ECTS Lecture contents General topics of statistics: exploratory data analysis basics of statistical inference statistical modeling, selection of models, logistic regression Assessment methods Homework, in class Participation, final examination Teaching methods Applied practice with "R" Language German	1	2
Behavior and Error Performance SE Behavior and Error Performance SE Lector: Georg Hochfellner, BSc MSc 1SWS 2ECTS Lecture contents • Definitions of errors • Reasons for errors in the person, in the system, in the organisation • Coping with criticism • Exercises in the communication of mistakes Assessment methods Continous assessments throughout the course Teaching methods Integrated course Language German	1	2
Auditing ILV Auditing ILV Lector: Ing. Mag.(FH) Wolfgang Pölz, MSc, MBA 0.5SWS 1ECTS Lecture contents 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. Assessment methods 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". Teaching methods Seminaristic work, theoretical impulses	0.5	1

3. Semester

Lecture	SWS	ECTS
Accreditation and Auditing ILV Accreditation and Auditing ILV Lector: Dr. Robert Leubolt 1SWS 2ECTS Lecture contents - 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 Assessment methods - written examination at the end of the course Teaching methods - Seminar - individuell work on specific examples in the area of auditing Language German	1	2
Industrial Facility Hygiene VO Industrial Facility Hygiene VO Lector: DI(FH) Robert Schwarz 1SWS 2ECTS Lecture contents 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. Assessment methods Written Exam and participation during lectures Teaching methods lectured course and participation Language German-English	1	2
Biosafety and Biosecurity VO Biosafety and Biosecurity VO Lector: Hon.-Prof. Univ.-Doz. DI Dr. Rudolf Friedrich Bliem 0.5SWS 1ECTS Lecture contents 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. Assessment methods Final Exam Teaching methods Lectured Course Language German-English	0.5	1
Business Plan and Cost Accounting ILV Business Plan and Cost Accounting ILV Lector: Mag. Dipl.-Ing. Dr. Martin Pfeffer, Mag. Karin Pfeffer 2SWS 4ECTS Lecture contents "hands-on" priciples in business administration Development of a business plan Assessment methods preparation & presentation of a business plan Teaching methods lecture, Workshop Language German	2	4
Data Mining and Visualization ILV Data Mining and Visualization ILV Lector: Dipl.-Ing. Barbara Lederer 1SWS 2ECTS Lecture contents Basic concepts of Data Mining Introduction into Visualization Pros and Cons in representations Practical exercises Assessment methods The examination consists of attendance, active participation as well as the grading of exercise work and presentations. Teaching methods Lecture plus exercise Language German	1	2
Energy Technology for Quality Management ILV Energy Technology for Quality Management ILV Lector: Univ.-Prof. DI Dr. Herbert Braun 1SWS 2ECTS Lecture contents 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) Assessment methods Examination Teaching methods lessons Language German	1	2
Good Clinical Practice and Pharmacovigilance VO Good Clinical Practice and Pharmacovigilance VO Lector: Mag. DDr. Alexander Hönel, MSc MBA LLM 1SWS 2ECTS Lecture contents 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. Assessment methods Presentation of the student and their evaluation as assessment Teaching methods Introduction into the topic as lecture, followed by selected topics to be presented by the student on the last day of the lecture. Language German-English	1	2
Quality Control and Quality Assurance in the Laboratory ILV Quality Control and Quality Assurance in the Laboratory ILV Lector: Dipl.Ing. Dr. Christine Prenner, Ao.Univ. Prof. DI Dr. Karola Vorauer-Uhl 2.5SWS 4ECTS Lecture contents 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. Assessment methods 30% presentation 30% homework 40% final, written examination each part need to be positive Teaching methods 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 Language German	2.5	4
Regulatory Requirements in Drug Licensing ILV Regulatory Requirements in Drug Licensing ILV Lector: Mag. Dr. Elke Litzlbauer, DI (FH) Jürgen Waditschatka, DI Dr. Christa Wirthumer-Hoche 1.5SWS 3ECTS Lecture contents 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. Assessment methods written assignment of the respective task including verbal presentation / questioning Teaching methods Lecture / Tutorial Language German-English	1.5	3
Statistical Process Control ILV Statistical Process Control ILV Lector: Dr. Moritz Imendörffer 1.5SWS 3ECTS Lecture contents 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 Assessment methods written exam Teaching methods lecture with excercises Language German	1.5	3
Materials Stream and Environmental Management ILV Materials Stream and Environmental Management ILV Lector: Mag. Dr. Andreas Franz 1SWS 2ECTS Lecture contents 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 Assessment methods written exam Teaching methods Lecture with the help of slides, added with practical examples Language German	1	2
Sterilization and Disinfection ILV Sterilization and Disinfection ILV Lector: Hon.-Prof. Univ.-Doz. DI Dr. Rudolf Friedrich Bliem 1SWS 2ECTS Lecture contents Terms and overview of processes for microbial inactivation Processes of moist heat inactivation, as well as chemical and thermal disinfection Predictive calculation models Assessment methods written exam Teaching methods lectured course Language German-English	1	2
ISO 45001 and integrated QM VO ISO 45001 and integrated QM VO Lector: Mag. Dr. Andreas Franz 0.5SWS 1ECTS Lecture contents 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 Assessment methods Written examination, presentation if necessary, online examinations if necessary in accordance with the hygienic requirements. Teaching methods Lecture, group work with presentation according to the possibilities (presence phase, online phase) Language German	0.5	1

4. Semester

Lecture	SWS	ECTS
Master Thesis Supervision AP Master Thesis Supervision AP 0SWS 1ECTS Lecture contents Preparation for the master´s degree examination Assessment methods Presentation with assessment of the master´s degree thesis and general examination Teaching methods -	0	1
Master Thesis MT Master Thesis MT 0SWS 28ECTS Lecture contents The content of this course is the writing of a diploma thesis. Assessment methods 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. Teaching methods 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.	0	28
Master Thesis Seminar SE Master Thesis Seminar SE Lector: Dipl.-Ing. Dr. Johanna Hämmerle 1SWS 1ECTS Lecture contents 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 methods Assessment of the given presentation (structure, slide deck, presentation style, timing). Teaching methods Presentation Language German	1	1

Semester dates
Summer semester 2020: 10th February to 12th July 2020
Winter semester 2020/21: 17th August 2020 to 31st January 2021

Number of teaching weeks
20 per semester

Times
6.00 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 instruction
German

Career opportunities

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:

Biopharmaceutical industry
Industrial biotechnology
Food industry
Environmental technology

Cosmetic industry
Plasmapheresis centers
Public health sector

Admission

Admission requirements

Bachelor degree in natural sciences-technology or similar qualification from an institute of higher education with a total of 180 ECTS credits

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.

Equivalent certification from abroad
Regulation for the admission of third country citizens
Information for applicants with non-Austrian (school) certificates

Equivalence is determined by international agreements, validation or in individual cases a decision by the head of the academic section.

Application

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:

Bachelor/diploma certificate or equivalent certificate from abroad

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.

List of courses completed or transcript
Letter of motivation
CV in table form

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.

Admission procedure

The admission procedure consists of a written test and an interview with the admission committee.

Aim
The aim is to ensure places are offered to those persons who complete the multi-level admission procedure with the best results. The tests are designed to assess the skills needed for an applicant's chosen profession.

Procedure
The written admission test assesses the applicant's knowledge of natural sciences, technology and quality management. Applicants then undergo an admission interview on the same day to provide a first impression of their personal aptitude. The qualities interviewers are looking for include professional motivation, an understanding of the profession, performance, time management. Points are assigned to each section of the test.

Criteria
The criteria for acceptance are based solely on performance. The geographical origin of the applicant has no influence on the admission decision. The admission requirements must be met in all cases. Completion of all parts of the admission procedure. Applicants are evaluated according to the following weighting system:
> Written admission test 60%
> Admission interview 40%

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.

laughing young man in white shirt talking to two women

Contact

> FH-Prof. DI Dr. Michael Maurer

Head of Degree Program Bioengineering, Bioinformatics, Biotechnological Quality Management, Bioprocess Engineering
T: +43 1 606 68 77-3601
michael.maurer@fh-campuswien.ac.at

Secretary's office

Map Muthgasse (Google Maps)

Office hours during semester
Mon to Thu, 4.30 p.m.-6.00 p.m.

By appointment
Mon to Thu, 10.00 a.m.-6.00 p.m.
Fri, 10.00 a.m.-1.00 p.m.

Teaching staff and research staff

> FH-Prof. DI Dr. Michael Maurer

Head of Degree Program Bioengineering, Bioinformatics, Biotechnological Quality Management, Bioprocess Engineering

Cooperations and Campusnetzwerk

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!

Campusnetzwerk

Downloads and Links

Information Biotechnological Quality Management Master (PDF)

Folder Applied Life Sciences (PDF)

Table of contents