Master

Biotechnological Quality Management

Biotechnological Quality Management

part-time

 

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

Application winter semester 2023/24

1st January to 31st May 2023

Study places

18

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

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

New study location from winter semester 2022/23: The Department of Applied Life Sciences will move to the new building at Favoritenstraße 222, 1100 Vienna in the summer of 2022.

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.

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.

  • Bachelor degree in natural sciences-technology or similar qualification from an institute of higher education with a total of 180 ECTS credits ith 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
    • Equivalence is determined by international agreements, validation or in individual cases a decision by the head of the academic section.

Regulation for the admission of third country citizens (PDF 233 KB)

Information for applicants with non-Austrian (school) certificates (PDF 145 KB)

There are 18 places available in the master's degree program in Biotechnology Quality Management each year. The ratio of places to applicants is currently around 1:3.

To apply you will require the following documents:

  • 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.
  • Proof of identity (copy of passport or copy of identity card)
  • In case German is not your first language: Proof of German language skills at level C1
  • 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.

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
May and June

Planned start of the first semester
Mid of August


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
1 SWS
2 ECTS

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

Parenterals VO
1 SWS
2 ECTS

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

Technical Risk Analysis ILV
1 SWS
2 ECTS

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

Bioprocesses and Products VO
1.5 SWS
3 ECTS

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

Introduction to GMP and Quality Management VO
1 SWS
2 ECTS

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 discussion
Homework

Language

German

Good Manufacturing Practice, Eudralex ILV
1 SWS
2 ECTS

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

Immunology VO
1 SWS
2 ECTS

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

Implementation of Analytical Methods UE
1.5 SWS
2 ECTS

Implementation of Analytical Methods UE

Lector: Horia-Paul Bunduc, 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

ISO 9001 ILV
1.5 SWS
3 ECTS

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

Physiology VO
1 SWS
2 ECTS

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

Validation ILV
1 SWS
2 ECTS

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

QM-System Development ILV
1 SWS
2 ECTS

QM-System Development ILV

Lector: Ing. Mag.(FH) Wolfgang Pölz, MSc, MBA

1 SWS   2 ECTS

Teaching methods

Seminaristic work, theoretical impulses

Language

German

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

Selected Subjects in Quality Management and Master Thesis Preparation SE

Lector: Ing. Mag.(FH) Wolfgang Pölz, MSc, MBA

1 SWS   2 ECTS

Lecture contents

.

Assessment methods

Course immanent

Teaching methods

Lecture and exercises. The Focus lies on Independent Problem solving.

Language

German

Selected topics in Quality Management VO
1 SWS
2 ECTS

Selected topics in Quality Management VO

Lector: Hon.-Prof. Univ.-Doz. DI Dr. Rudolf Friedrich Bliem, Dipl.-Ing. Gerald Holzmann, Bakk. techn., Dr. Roman Käfer

1 SWS   2 ECTS

Lecture contents

Extending and deepening the contents of the course "Einführungen in GMP und Qualitätsmanagement" varied lectured and practical coursework.

Assessment methods

written test

Teaching methods

Lecture, discussion, practical

Language

German

External and internal auditing VO
0.5 SWS
1 ECTS

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

Process Modelling and Simulation ILV
2.5 SWS
5 ECTS

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)

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

Specific Statistics Practice UE
1 SWS
2 ECTS

Specific Statistics Practice UE

Lector: Eva Valerie Lehner, BSc, Dipl.-Ing. Dr. Alexandra Posekany

1 SWS   2 ECTS

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

Biopharmakology VO
1.5 SWS
3 ECTS

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

Introduction to Operations Research VO
1 SWS
2 ECTS

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

Optimization Methods UE
1 SWS
2 ECTS

Optimization Methods UE

Lector: Dipl.-Ing. Gerald Holzmann, Bakk. techn.

1 SWS   2 ECTS

Lecture contents

Solving optimization problems using XPress.

Assessment methods

Practices and final exam.

Teaching methods

- lecture
- practice
- examples

Language

German

Pharmaceutical Technology ILV
2 SWS
4 ECTS

Pharmaceutical Technology ILV

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

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

QM in Food Production VO
1 SWS
2 ECTS

QM in Food Production VO

Lector: Mag.(FH) DI Dr. Markus Dürrschmid

1 SWS   2 ECTS

Lecture contents

Legal requirements for food in the context of European and national legislation
Requirements from currently applicable food standards (IFS etc.)
Requirements for GHP (Good Hygiene Practice) in food production in accordance with applicable standards
Basics of implementing a HACCP system
Practical exercises for the implementation and evaluation of a QM system in food production

Assessment methods

written examination

Teaching methods

introduction and examination (presence modules)
working in groups and private studies (distance learning)
presentation of results (group work) incl. discussion (ZOOM presentation)

Language

German

Six Sigma, Lean, Kaizen ILV
2 SWS
4 ECTS

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

Specific Statistics ILV
1 SWS
2 ECTS

Specific Statistics ILV

Lector: Dipl.-Ing. Dr. Alexandra Posekany

1 SWS   2 ECTS

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

Behavior and Error Performance SE
1 SWS
2 ECTS

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

Auditing ILV
0.5 SWS
1 ECTS

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

Accreditation and Auditing ILV
1 SWS
2 ECTS

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

Industrial Facility Hygiene VO
1 SWS
2 ECTS

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

Biosafety and Biosecurity VO
0.5 SWS
1 ECTS

Biosafety and Biosecurity VO

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

0.5 SWS   1 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

Business Plan and Cost Accounting ILV
2 SWS
4 ECTS

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
Development of a business plan

Assessment methods

preparation & presentation of a business plan

Teaching methods

lecture, Workshop

Language

German

Data Mining and Visualization ILV
1 SWS
2 ECTS

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

Energy Technology for Quality Management ILV
1 SWS
2 ECTS

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

Teaching methods

lessons

Language

German

Good Clinical Practice and Pharmacovigilance VO
1 SWS
2 ECTS

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

Quality Control and Quality Assurance in the Laboratory ILV
2.5 SWS
4 ECTS

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 praxis and general requirements of active pharmaceutical ingredients and excipients

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

Regulatory Requirements in Drug Licensing ILV
1.5 SWS
3 ECTS

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

Statistical Process Control ILV
1.5 SWS
3 ECTS

Statistical Process Control ILV

Lector: Dr. Moritz Imendörffer

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

Materials Stream and Environmental Management ILV
1 SWS
2 ECTS

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

Sterilization and Disinfection ILV
1 SWS
2 ECTS

Sterilization and Disinfection ILV

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

ISO 45001 and integrated QM VO
0.5 SWS
1 ECTS

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

Master Thesis Supervision AP
0 SWS
1 ECTS

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

Master Thesis MT
0 SWS
28 ECTS

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

Master Thesis Seminar SE
1 SWS
1 ECTS

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

Semester dates
Winter semester: Mid of August to end of January
Summer semester: Beginning of February to mid of July

Number of teaching weeks
20 per semester

Times
6.00 p.m. to 9.20 p.m. (ca. four times from Mon to Fri), Sat ca every two weeks from at 8:30 a.m. (allday)


After graduation

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


      Studying made easy

      Bücher mit Geld
      Funding & Scholarships

      More information here

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      Hände zeigen auf Weltkarte
      Time abroad

      Expertise, language skills, broadening horizons

      >
      Fish jumps out of fishbowl into another fishbowl
      Open Lectures

      Find out more, in German

      >
      Books and laptop
      Center for academic writing
      >
      Intensive German course
      >
      Start-up Service
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      Doctoral Service
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      Validation
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      Accessibility
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      queer @ FH Campus Wien
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      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!


      Contact

      Head of Degree Program

      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


      Downloads

      Information Biotechnological Quality Management Master
      pdf, 97 KB
      Folder Applied Life Sciences
      pdf, 906 KB
       

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