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

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

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

Lecture contents

This course will introduce biological and biotechnological manufactured products with the focus on medicinal products (blood products, vaccines, recombinant proteins, monoclonal antibodies, biosimilars). Basic considerations on technological processes and manufacturing methods as well as analytical methods and considerations of viral safety will be presented. Genetic and immunological principles in the context of modern, biological medicinal therapies will be reviewed.
Practical approaches for utilization of the products and for working in the biotech environment will be highlighted (key player in the biotech industry, vaccination programs, biotech company, license).

Assessment methods

Final Exam

Teaching methods

Lecture

Language

German

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

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

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

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

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

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

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 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).

Written Final Exam (multiple choice, text questions and sample calculations)

Weighting of the final grade:
Written Exam 60% and blended learning tasks 40% (each part must be completed with a positive grade)

Teaching methods

Lecture (WS20/21 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

Lecture contents

Creation and, to a limited extent, the implementation of a quality management system. Furthermore, this course is oriented towards the subsequent LV external and internal audit.

Assessment methods

Active cooperation, written and oral examination at the end of the course "auditing", which also includes the course "external and internal auditing" and "development of the QMS".

Teaching methods

Seminaristic work, theoretical impulses

Language

German

Lecture contents

.

Assessment methods

Course immanent

Teaching methods

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

Language

German

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

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)

Assessment methods

Collaboration, tests, challenges, group work, presentations, practice examples, final exam

Teaching methods

Lecture, surveys, presentation and discussion in online sessions. Literature study and assigements in self-study modules.

Language

German

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

Lecture contents

Basics of pharmacology and toxicology

Assessment methods

written exam with multiple choice and open questions

Teaching methods

Lecture

Language

German

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

Lecture contents

Solving optimization problems using XPress.

Assessment methods

Practices and final exam.

Teaching methods

- lecture
- practice
- examples

Language

German

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

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

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

Language

German

Lecture contents

See German description

Assessment methods

Exam

Teaching methods

See German description

Language

German

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

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

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

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

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 adventitious product contamination and through specific forms of implementation and instruments.

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 less than 60 % of the required performance were provided in addition, following directly the 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 60% and blended learning tasks 40% (each part must be completed with a positive grade)

Teaching methods

Lecture (WS20/21 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 final exam.

Language

German-English

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

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

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

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

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

Lecture contents

This course is focused on Quality Assurance and Quality control aspects and strategies. Both GMP and ISO/IEC 17025 systems will be introduced. Therefore, general rules but also similarities and differences will be addressed. The dynamic development in both systems and their consequences will be discussed accordingly.

Assessment methods

30% presentation
30% homework
40% final, written examination

each part need to be positive

Teaching methods

The course has been established as an interactive workshop subdivided into a homework part and an attendance part. For the work at home general documents and specific documents for the presentations are presented on the moodle platform. The individual presentations, discussion and selected examples will be done in the attendance time. Further and more detailed instruction are given on the moodle plattform

Language

German

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

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

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

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

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

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

-

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.

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