bioqm01_m_en

Biotechnological Quality Management

Master, part-time

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.

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Contact us

Contact us!

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

Office hours:
Mon. to Thu. 4:00 p.m. to 6:00 p.m.

By appointment
Mon. to Thu. 10:00 a.m. to 6:00 p.m.
Fri. 10:00 a.m. to 1:00 p.m.

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Stay up to date!

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 2018/19

1st November 2017 to 15th June 2018

tuition fee / semester:

€ 363,36*

+ 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)

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.

 

 


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

Grundstudium

Lecture SWS ECTS
Bioprocesses and Products VO

Bioprocesses and Products VO

Lector: Dr. MMag. Agnes Bugajska-Schretter, Dipl.-Ing. Helga Sgardelli, Dr. Martin Spruth

1.5 SWS
3 ECTS

Lecture contents

This course will introduce biological and biotechnological manufactured products with the focus on medicinal products (blood products, vaccines, recombinant proteins, biosimilars). Basic knowledge on technological processes and manufacturing methods as well as on genetics, immunology and history of biotechnology will be summarized.
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 Programming VO+UE

Introduction to Programming VO+UE

Lector: Dipl.-Ing. Gerald Holzmann, Bakk. techn., Silvia Schmidt, MSc

2 SWS
4 ECTS

Lecture contents

Basic concepts of programming
JAVA characteristics
Statements and data types
Control sequences
Basics of object-oriented programming
Basic program design
Error handling

Assessment methods

home exercises, written exam

Teaching methods

Talk, exercises

Language

German

2 4
Introduction to GMP and Quality Management VO

Introduction to GMP and Quality Management VO

Lector: Hon.-Prof. Univ.-Doz. DI Dr. Rudolf Friedrich Bliem

1 SWS
2 ECTS

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 discussionHomework

Language

German

1 2
Good Manufacturing Practice, Eudralex VO+UE

Good Manufacturing Practice, Eudralex VO+UE

Lector: Frank Kasteliz

1 SWS
2 ECTS

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 and oral examination 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

1 SWS
2 ECTS

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

1.5 SWS
2 ECTS

Lecture contents

Implementing an analytical method to practice the validation of analytical methods in depth

Assessment methods

interactive participationAssessment of practical work and authoring of all validation documents

Teaching methods

Lectured practical

Language

German

1.5 2
ISO 9001, Systems Implementation and Auditing VO+UE

ISO 9001, Systems Implementation and Auditing VO+UE

Lector: Georg Hochfellner, BSc

1.5 SWS
3 ECTS

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
Parenterals VO

Parenterals VO

Lector: O.Univ.-Prof. Mag.pharm. Dr. Helmut Viernstein

1 SWS
2 ECTS

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
Physiology VO

Physiology VO

Lector: Mag. Dr. Oliver Kudlacek, Priv.Doz.in Dr.in Dagmar Stoiber-Sakaguchi

1 SWS
2 ECTS

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
Technical Risk Analysis VO+UE

Technical Risk Analysis VO+UE

Lector: Dr. Reinhard Preiss

1 SWS
2 ECTS

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
Validation VO+UE

Validation VO+UE

Lector: DI(FH) Robert Schwarz

2 SWS
4 ECTS

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 50%, active participation and documents 25% each

Teaching methods

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.

Language

German-English

2 4
Technical Risk Analysis Practice UE

Technical Risk Analysis Practice UE

Lector: Dr. Reinhard Preiss

1 SWS
2 ECTS

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

Grundstudium

Lecture SWS ECTS
Selected Subjects in Quality Management and Master Thesis Preparation SE

Selected Subjects in Quality Management and Master Thesis Preparation SE

Lector: Hon.-Prof. Univ.-Doz. DI Dr. Rudolf Friedrich Bliem, Dr. Martin Hofer, MSc MBA

1 SWS
2 ECTS

Lecture contents

Role of natural IgM antibodies in immune surveillance
Structure and function of natural IgM antibodies
Manufacturing platforms for IgM antibodies
Quality management of natural IgMs
? why are natural IgM antibodies not in use for immuno-therapeutic applications ?

Assessment methods

Course immanent

Teaching methods

Lecture and exercises. The focus lies on independent problem solving.

Language

German

1 2
Biopharmakology VO

Biopharmakology VO

Lector: Mag. Dr. Oliver Kudlacek, Priv.Doz.in Dr.in Dagmar Stoiber-Sakaguchi

1.5 SWS
3 ECTS

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

1 SWS
2 ECTS

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 lectureThe 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.

1 SWS
2 ECTS

Lecture contents

Solving optimization problems using XPress.

Assessment methods

recurring tests, practices and final exam.

Teaching methods

- lecture- practice- examples

Language

German

1 2
Pharmaceutical Technology VO+UE

Pharmaceutical Technology VO+UE

Lector: MMag. Dipl.-Ing. Dr. Monika Müller, Herbert Sulzbacher, Mag. Dr. Stefan Tögel, O.Univ.-Prof. Mag.pharm. Dr. Helmut Viernstein

2 SWS
4 ECTS

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
Process Modelling and Simulation VO+UE

Process Modelling and Simulation VO+UE

Lector: Dr. Christian Fikar, MSc, Dipl.-Ing. Martin Pernkopf, BSc

2.5 SWS
5 ECTS

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

LectureGroup WorkHands-on experience with the simulation software 'AnyLogic'

2.5 5
QM in Food Production VO

QM in Food Production VO

Lector: Dr. Martin Hofer, MSc MBA

1 SWS
2 ECTS

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

2 SWS
4 ECTS

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

1 SWS
2 ECTS

Lecture contents

General topics of statistics:
statistical modeling, selection of models
generalized models (logistic regression)
bayesian estimate and modeling

Assessment methods

Participation, final examination

Teaching methods

Applied practice with "R"

Language

German

1 2
Specific Statistics Practice UE

Specific Statistics Practice UE

Lector: Dipl.-Ing. Dr. Alexandra Posekany

1 SWS
2 ECTS

Lecture contents

General topics of statistics:
statistical modeling, selection of models
generalized models (logistic regression)
bayesian estimate and modeling

Assessment methods

continous assessments throughout the course and final examination

Teaching methods

Applied practice with "R"

1 2
Behavior and Error Performance SE

Behavior and Error Performance SE

Lector: Georg Hochfellner, BSc

1 SWS
2 ECTS

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

Grundstudium

Lecture SWS ECTS
Accreditation and Auditing VO+UE

Accreditation and Auditing VO+UE

Lector: Dr. Robert Leubolt

1 SWS
2 ECTS

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

1 SWS
2 ECTS

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, Mag. Rupert Bliem

1 SWS
2 ECTS

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

1 2
Business Plan and Cost Accounting VO+UE

Business Plan and Cost Accounting VO+UE

Lector: Mag. Dipl.-Ing. Dr. Martin Pfeffer, Mag. Karin Pfeffer

2 SWS
4 ECTS

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 VO+UE

Data Mining and Visualization VO+UE

Lector: Dipl.-Ing. Barbara Kavšek

1 SWS
2 ECTS

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 the exercisework.

Teaching methods

Lecture plus exercise

Language

German

1 2
Energy Technology for Quality Management VO+UE

Energy Technology for Quality Management VO+UE

Lector: Univ.-Prof. DI Dr. Herbert Braun

1 SWS
2 ECTS

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

1 SWS
2 ECTS

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 VO+UE

Quality Control and Quality Assurance in the Laboratory VO+UE

Lector: Dipl.Ing. Dr. Christine Prenner, Prof. Dr. Karola Vorauer-Uhl

2.5 SWS
4 ECTS

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% presentation30% groupwork40% final, written examinationeach 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 VO+UE

Regulatory Requirements in Drug Licensing VO+UE

Lector: Mag. Dr. Elke Litzlbauer, DI (FH) Jürgen Waditschatka, DI Dr. Christa Wirthumer-Hoche

1.5 SWS
3 ECTS

Lecture contents

This lecture gives a broad overview of the regulatory requirements for licensure of biological/ biotech products. The main aspects of the European RA environment will be presented, discussed and supported by practical examples. The gained theoretical knowledge will be needed and put into practice solve the case studies of the “Projektarbeit”.

Assessment methods

Lecture: Written ExamProjektarbeit (case studies): verbal presentation (incl. questions/ discussion) + written assignment of the respective case study

Teaching methods

Lecture/ Projektarbeit (case studies)

Language

German-English

1.5 3
Statistical Process Control VO+UE

Statistical Process Control VO+UE

Lector: Dipl.-Ing. Florian Jantscher, PhD

1.5 SWS
3 ECTS

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
Sterilization and Disinfection VO+UE

Sterilization and Disinfection VO+UE

Lector: Hon.-Prof. Univ.-Doz. DI Dr. Rudolf Friedrich Bliem

1 SWS
2 ECTS

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
Materials Stream and Environmental Management VO+UE

Materials Stream and Environmental Management VO+UE

Lector: Mag. Dr. Andreas Franz

1 SWS
2 ECTS

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

Grundstudium

Lecture SWS ECTS
Master Thesis Supervision MT 1 1
Master Thesis MT 0 28
Master Thesis Seminar SE

Master Thesis Seminar SE

Lector: Dipl.-Ing. Dr. Johanna Hämmerle

1 SWS
1 ECTS

Lecture contents

Methodology for pursuing and writing of the diploma thesis:
clarification of the procedure through presentations of the theses

Assessment methods

Assessment of the presentations

Teaching methods

Presentations

Language

German

1 1

Semester dates
Winter semester: 16th August 2017 to 27th January 2018
Summer semester: 5th February 2018 to 14th July 2018

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: Info sheet (PDF)

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 1:1,5.

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
  • Proof of residence

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 selection process

The selection process consists of a written test and an interview with the selection committee.

  • Aim
    The aim is to ensure places are offered to those persons who complete the multi-level selection process with the best results. The tests are designed to assess the skills needed for an applicant's chosen profession.
  • Procedure
    The written selection test assesses the applicant's knowledge of natural sciences, technology and quality management. Applicants then undergo a selection 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 selection decision. The admission requirements must be met in all cases.  Completion of all parts of the selection process. Applicants are evaluated according to the following weighting system:
    > Written selection test 60%
    > Selection 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 selection process are documented in a transparent and verifiable manner.

Secretary's office

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

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


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