Biotechnological Quality Management

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.

Department

Applied Life Sciences

Topic

Technologies

Facts

Final degree: Master of Science in Engineering (MSc)

Duration of course: 4 Semesters

Organisational form: part-time

Tuition fee per semester € 363,36¹ + ÖH premium + contribution²

ECTS: 120 ECTS

Language of instruction: German, part. English

Currently no application possible

Study places: 18

¹ Tuition fees for students from third countries € 727,- per semester. Details on tuition fees can be found in the general fee regulations.
²for additional study expenses (currently up to € 83,- depending on degree program and year)

Before the studies

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

Why you should study with us

Study place = lab place

Sharing is good, however, not your lab space, please. You are guaranteed your own.

Highly sought-after knowledge

What you learn here is crucial to solving global problems.

International network

Going abroad for an internship or a job: this is the next logical step when studying with us.

Relevant admission requirement

The relevant admission requirement is

a completed Bachelor's degree in natural sciences and technology or
an equivalent degree at a recognized domestic or foreign post-secondary educational institution.

A total of 180 ECTS and of which at least

60 ECTS credits from natural science subjects such as chemistry, microbiology, mathematics, statistics, biochemistry, molecular biology and
13 ECTS credits from technical subjects such as process engineering, fundamentals of bioprocess technology, measurement and control technology, quality management, technical law.

For further information, please contact the secretary's office.

Language requirements for admission

The required language level according to the Common European Framework of Reference for Languages (CEFR) is at least

German - level C1.

Legalization of foreign documents

Applicants may require legalization of documents from countries other than Austria in order for them to have the evidential value of domestic public documents. Information on the required legalizations can be found here in PDF format.

Legalization of foreign documents in higher education
Federal ministry Education, Science and Research

open

Translation of your documents

For documents that are neither in German nor English, a translation by a sworn and court-certified interpreter is required. Your original documents should have all the necessary legalization stamps before translation so that the stamps are also translated. The translation must be firmly attached to the original document or a legalized copy.

Online application - uploading documents

As part of your online application, upload scans of your original documents including all required legalization stamps. For documents not issued in German or English, scans of the corresponding translations must also be uploaded. The head of the study program decides on the equivalence of international (higher) education qualifications. Therefore, your documents can only be checked as part of the ongoing application process.

Your path to studying at FH Campus Wien begins with your registration on our application platform. In your online account, you can start your application directly or activate a reminder if the application phase has not yet started.

There are 18 places available each year on the Master's degree program Biotechnological Quality Management. The ratio of study places to applicants is currently approx. 1:3.

Documents for your online application

Proof of identity
- passport or
- identity card or
- Austrian driving license (proof of citizenship required) or
- residence permit (proof of citizenship required)
Proof of change of name, if applicable (e.g. marriage certificate)
Proof of fulfillment of the relevant admission requirement
- degree certificate and
- Transcript of Records or Diploma Supplement (see also no. 4)
- If you have not yet completed your studies, please upload proof of all courses completed to date as part of the relevant degree program, including ECTS credits.
(optional in a 2nd file) Transcript of Records or Diploma Supplement (see no. 3)
Proof of German level C1 according to the Common European Framework of Reference for Languages (CEFR). The following apply as proof:
- secondary school leaving certificate from a German-speaking school
- completion of at least three years of studies in German
- supplementary examination pre-study course - German C1
- German certificate (not older than 3 years), e.g.:
  - Austrian German Language Diploma: ÖSD Certificate C1
  - Goethe Institute: Goethe Certificate C1
  - telc: German C1 University
  - German language test for university admission for foreign applicants: DSH-2
  - German Language Diploma of the Standing Conference of the Ministers of Education and Cultural
    Affairs of the Länder in the Federal Republic of Germany: DSD II - C1
  - Test of German as a foreign language (Test DaF): Level TDN 4 in all parts
  - Language Center of the University of Vienna: Course and successfully passed exam at level C1/2
  - Proof of a higher language level is also valid.
Curriculum vitae in tabular form in German
Letter of motivation in German
Legalizations and translations, if applicable (see tab “Foreign documents and degrees”)

Your application is valid once you have completely uploaded the required documents. If you do not have all the documents at the time of your online application, please submit them to the secretary's office by email as soon as you receive them.

After completing your online application, you will receive an email confirmation with information on the next steps.

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.

Written test and interview
Between April and June, details will be available when the application is open.

Planned start of the first semester
Mid of August

Do you still have questions about the study?

Make an appointment with Elisabeth Holzmann (Secretary's office) elisabeth.holzmann@fh-campuswien.ac.at for a a personal consultation via Zoom.

During the studies

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.

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

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 SWS

2 ECTS

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
Language
German

1 SWS

2 ECTS

Technical Risk Analysis ILV
Technical Risk Analysis ILV
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 SWS

2 ECTS

Bioprocesses and Products VO
Bioprocesses and Products VO
Lector: Dr. MMag. Agnes Bugajska-Schretter, DI (FH) DI Dr. Juan Antonio Hernandez Bort
1.5 SWS 3 ECTS
Lecture contents
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.
Assessment methods
Final Exam
Teaching methods
Lecture
Language
German

1.5 SWS

3 ECTS

Good manufacturing practice and pharmaceutical quality management VO
Good manufacturing practice and pharmaceutical quality management VO
Lector: Barbara Feldhofer, MSc
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
Final exam

Written exam
Teaching methods
Lecture with discussion
Language
German

1 SWS

2 ECTS

Good Manufacturing Practice, Eudralex ILV
Good Manufacturing Practice, Eudralex ILV
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 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 SWS

2 ECTS

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 SWS

2 ECTS

Implementation of Analytical Methods UE
Implementation of Analytical Methods UE
Lector: Barbara Feldhofer, MSc, Lukas Herzog, BSc, Ing. DI (FH) Dr. Harald Kühnel, MSc, Laurentius Orsolic, BSc
1.5 SWS 2 ECTS
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 SWS

2 ECTS

ISO 9001 ILV
ISO 9001 ILV
Lector: Georg Hochfellner, BSc MSc
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 SWS

3 ECTS

Physiology VO
Physiology VO
Lector: Mag. Dr. Oliver Kudlacek, DI Dr. Herwig Moll
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 SWS

2 ECTS

Validation ILV
Validation ILV
Lector: DI (FH) Robert Schwarz
1 SWS 2 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 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 75% and blended learning tasks 25% (each part must be completed with a positive grade)
Teaching methods
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.
Language
German-English

1 SWS

2 ECTS

QM-System Development ILV
QM-System Development ILV
Lector: Ing. Mag.(FH) Wolfgang Pölz, MSc, MBA
1 SWS 2 ECTS
Lecture contents
Learning and practicing the creation and, to a limited extent, the implementation of a quality management system. Furthermore, this course is oriented towards the subsequent course External and Internal Audit.
The following topics are covered in depth:
> Basic understanding of organizations
> Basic logic of management systems
> Historical development of management systems
> change management
> Project management
> Customer satisfaction
> Accreditation
> Performance problems
> QM tools
> Selected topics of ISO 9001:2015
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 SWS

2 ECTS

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
1 SWS 2 ECTS
Lecture contents
Creation and, to a limited extent, implementation of a quality management system. Furthermore, the contents of ISO 9001:2015 as well as auditing and the EFQM model are covered in depth.
The following topics are covered in depth:
> Selected topics of ISO 9001:2015
> Organizational development and transformation
> Managing knowledge
> Continuous improvement process
> EFQM model
> Selected management system tools (BSC, Kano; SWOT; OKR; Hoshin Kanri)
Assessment methods
Course immanent
Teaching methods
Lecture and exercises. The Focus lies on Independent Problem solving.
Language
German

1 SWS

2 ECTS

Selected topics in Quality Management VO
Selected topics in Quality Management VO
Lector: DI (FH) Christiane Gebhard, Bakk.tech, MSc., PhD, Celestine Hackl, BSc, Dipl.-Ing. Gerald Holzmann, Bakk. techn., Dr. Roman Käfer
1 SWS 2 ECTS
Lecture contents
Part 1:
Extending and deepening the contents of the course "Gute Herstellungspraxis und Pharmazeutisches Qualitätsmanagement" varied lectured and practical coursework.

Part 2:
Students are introduced to the technical tools for mapping algorithms.
To this end, the structures and working methods of programming are explained using pseudocode.
Assessment methods
written test
Teaching methods
Lecture, discussion, practical
Language
German

1 SWS

2 ECTS

External and internal auditing VO
External and internal auditing VO
Lector: Ing. Mag.(FH) Wolfgang Pölz, MSc, MBA
0.5 SWS 1 ECTS
Lecture contents
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".
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

0.5 SWS

1 ECTS

Process Modelling and Simulation ILV
Process Modelling and Simulation ILV
Lector: Dr. Ing. Christoph Kogler, MSc. BSc.
2.5 SWS 5 ECTS
Lecture contents
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)

This course was nominated for the Ars Docendi (State Prize for Teaching) by the Rectorate and the student Council of FH Campus Wien in 2023 and included in the Atlas of Good Teaching by the Federal Ministry of Education, Science and Research (detailed didactic description at bit.ly/ATLASFH). In 2022, the course was selected by the jury of FH Campus Wien as a best practice e-learning project in the flipped classroom category and the project description on the FH intranet has since served as inspiration for other teachers .
Assessment methods
Collaboration, tasks, tests, challenges, group work, presentations, practice examples
Teaching methods
Lecture, surveys, presentation and discussion in online sessions. Literature study and assigements in self-study modules.
Language
German

2.5 SWS

5 ECTS

Specific Statistics Practice UE
Specific Statistics Practice UE
Lector: Florian Hamacsek, Dipl.-Ing. Dr. Alexandra Posekany
1 SWS 2 ECTS
Lecture contents
The course deals with the practical application of general statistical topics in the context of biostatistics:
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 SWS

2 ECTS

Biopharmakology VO
Biopharmakology VO
Lector: Mag. Dr. Oliver Kudlacek, DI Dr. Herwig Moll
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 SWS

3 ECTS

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 lecture
The last unit is planned for the final written test.
Language
German

1 SWS

2 ECTS

Optimization Methods UE
Optimization Methods UE
Lector: Mag. Wolfgang Kreiter
1 SWS 2 ECTS
Lecture contents
Solving optimization problems using the Excel-solver and XPress.
Assessment methods
Practices and final exam.
Teaching methods
- lecture
- practice
- examples
Language
German

1 SWS

2 ECTS

Pharmaceutical Technology ILV
Pharmaceutical Technology ILV
Lector: Mag. Dr. Theresa Balber, Ap. Prof. Dr. Cecile Philippe, Andreas Schirmbrand, Assoc.Prof. Priv.Doz. 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 SWS

4 ECTS

QM in Food Production VO
QM in Food Production VO
Lector: Dr.nat.techn. Rubina Rumler, Msc
1 SWS 2 ECTS
Lecture contents
The course covers the basics of quality management (QM) in food production, taking into account relevant legal requirements, including Regulation (EU) No. 178/2002 (basic food regulation), Regulation (EU) No. 852/2004 (food hygiene) and Regulation (EU) No. 1169/2011 (food labeling). The focus is on good manufacturing practice (GHP), HACCP and common QM systems and certifications (ISO 9001, FSSC 22000, IFS). Students learn to use quality tools for process control, traceability and continuous improvement. Practical exercises support the implementation and evaluation of a QM system in food production.
Assessment methods
Active presence, elaboration and written exam
Teaching methods
Introduction and theory lecture in presence/ online
Development of an HACCP concept
Solving practical case studies
Presenting the results in presence
Exam in presence
Language
German

1 SWS

2 ECTS

Six Sigma, Lean, Kaizen ILV
Six Sigma, Lean, Kaizen ILV
Lector: Ing. Gerald Berger
2 SWS 4 ECTS
Lecture contents
See German description
Assessment methods
Exam
Teaching methods
See German description
Language
German

2 SWS

4 ECTS

Specific Statistics ILV
Specific Statistics ILV
Lector: Dipl.-Ing. Dr. Alexandra Posekany
1 SWS 2 ECTS
Lecture contents
General topics of statistics in context of biostatistics:
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 SWS

2 ECTS

Behavior and Error Performance SE
Behavior and Error Performance SE
Lector: Georg Hochfellner, BSc MSc
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 SWS

2 ECTS

Auditing ILV
Auditing ILV
Lector: Dr. Roman Käfer, Ing. Mag.(FH) Wolfgang Pölz, MSc, MBA
0.5 SWS 1 ECTS
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
Language
German

0.5 SWS

1 ECTS

Accreditation and Auditing ILV
Accreditation and Auditing ILV
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 SWS

2 ECTS

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
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)
Teaching methods
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.
Language
German-English

1 SWS

2 ECTS

Biosafety and Biosecurity VO
Biosafety and Biosecurity VO
Lector: Barbara Feldhofer, MSc
0.5 SWS 1 ECTS
Lecture contents
See german description
Assessment methods
Final Exam
Teaching methods
Lectured Course
Language
German-English

0.5 SWS

1 ECTS

Business Plan and Cost Accounting ILV
Business Plan and Cost Accounting ILV
Lector: Mag. Dipl.-Ing. Dr. Martin Pfeffer, Mag. Karin Pfeffer
2 SWS 4 ECTS
Lecture contents
"hands-on" priciples in business administration
Assessment methods
preparation & presentation of a business plan
Teaching methods
lecture, Workshop
Language
German

2 SWS

4 ECTS

Data Mining and Visualization ILV
Data Mining and Visualization ILV
Lector: Dipl.-Ing. Barbara Lederer
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 exercise
work and presentations.
Teaching methods
Lecture plus exercise
Language
German

1 SWS

2 ECTS

Energy Technology for Quality Management ILV
Energy Technology for Quality Management ILV
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 (Moodle)
Teaching methods
lessons
Language
German

1 SWS

2 ECTS

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 SWS

2 ECTS

Quality Control and Quality Assurance in the Laboratory ILV
Quality Control and Quality Assurance in the Laboratory ILV
Lector: DI Emerich Grassinger, Ing. Manfred Karner, Mag.rer.nat. Wolfgang Prader, Mag. Irene Schellenberger, DI Maximilian Schreiner, Dr. Philipp Steffen
2.5 SWS 4 ECTS
Lecture contents
This course is focused on quality control within the pharmaceutical industry. Specially we will look at the organization of the labs, personal and equipment qualification, method transfer and validation, pharmacopeias, reference substances, data integrity, inspections, sampling, good laboratory practice and general requirements of active pharmaceutical ingredients and excipients.
Assessment methods
Written exam (multiple choice and open-text questions)
Teaching methods
The course has been established as an interactive workshop subdivided into distance learning parts and attendance parts.
Language
German

2.5 SWS

4 ECTS

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
1.5 SWS 3 ECTS
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 SWS

3 ECTS

Statistical Process Control ILV
Statistical Process Control ILV
Lector: Ing. Gerald Berger
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 SWS

3 ECTS

Materials Stream and Environmental Management ILV
Materials Stream and Environmental Management ILV
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
Presentation of a group work on a given topic
Teaching methods
Lecture with the help of slides, added with practical examples
Language
German

1 SWS

2 ECTS

Sterilization and Disinfection ILV
Sterilization and Disinfection ILV
Lector: Barbara Feldhofer, MSc
1 SWS 2 ECTS
Lecture contents
Hygenic Design, 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 SWS

2 ECTS

ISO 45001 and integrated QM VO
ISO 45001 and integrated QM VO
Lector: Mag. Dr. Andreas Franz
0.5 SWS 1 ECTS
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 SWS

1 ECTS

Master Thesis Supervision AP
Master Thesis Supervision AP
Lector: FH-Prof. DI Dr. Michael Maurer
0 SWS 1 ECTS
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
-
Language
German

0 SWS

1 ECTS

Master Thesis MT
Master Thesis MT
Lector: FH-Prof. DI Dr. Michael Maurer
0 SWS 28 ECTS
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.
Language
German

0 SWS

28 ECTS

Master Thesis Seminar SE
Master Thesis Seminar SE
Lector: Ing. DI (FH) Dr. Harald Kühnel, MSc, FH-Prof. DI Dr. Michael Maurer
1 SWS 1 ECTS
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 SWS

1 ECTS

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
Mon - Fri 6.15pm until 9.30pm
Saturday from 8.45am

Studying made easy

Funding & Scholarships

More information here

Time abroad

Expertise, language skills, broadening horizons

Fish jumps out of fishbowl into another fishbowl

Open Lectures

Find out more, in German

Center for academic writing

Intensive German course

EICC

Doctoral Service

Validation

Accessibility

queer @ FH Campus Wien

Networking with graduates and organizations

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!

After graduation

As a graduate of this program, a wide range of occupational fields and career opportunities are open to you. Find out here where your path can take you.

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

Contact

Head of Degree Program

FH-Prof. DI Dr. Michael Maurer

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

Secretary's office

Elisabeth Beck
Elisabeth Holzmann, Bakk. techn.
Johanna Bauer
Barbara Philipp

Favoritenstraße 222, E.3.22
1100 Vienna
+43 1 606 68 77-3600
+43 1 606 68 77-3609
bioengineering@fh-campuswien.ac.at

Main Campus Favoriten (Google Maps)

Office hours during semester
Mo to Thur, 4.30 p.m. to 6.15 p.m.

Availability by phone
Mo to Thur, 10.00 a.m. to 6.15 p.m
Fr, 10.00 a.m. to 2.00 p.m

Teaching staff and research staff

Ing. DI (FH) Dr. Harald Kühnel, MSc

Academic Staff

Master's Degree Program

Biotechnological Quality Management

Biotechnological Quality Management