Overview Quality management in the strict context of Good Manufacturing Practice is a legal requirement in particular for the biopharmaceutical industry.The necessary management optimization also opens up a wide range of opportunities.The degree program provides both.Biotechnological Quality Management combines technical expertise with management methods.The degree program focuses on quality management for biotechnological processes and products including Good Manufacturing Practice.As a graduate, you will develop and realize customer-oriented products and improve the company-internal process quality.Contact usContact us!Elisabeth BeckElisabeth Holzmann, Bakk.techn.Johanna BauerBarbara PhilippMuthgasse 621190 ViennaT: +43 1 606 68 77-3600F: +43 1 606 68 77-3609bioengineering@fh-campuswien.ac.atMap Muthgasse (Google Maps)Office hours during semesterMon to Thu, 4.30 p.m.-6.00 p.m. By appointmentMon to Thu, 10.00 a.m.-6.00 p.m.Fri, 10.00 a.m.-1.00 p.m.Duration of course4 SemesterFinal degreeMaster of Science in Engineering (MSc)18Study places120ECTSOrganisational formpart-timeApplication period for academic year 2021/221st January 2021 to 15th June 2021tuition fee / semester:€ 363,361+ ÖH premium + contribution2 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) What you can offer You have basic know-how in natural sciences, process engineering and quality management. In addition, you have an above-average risk-benefit awareness and are an analytical and process-oriented thinker. You enjoy working on projects in a team and would like to take on management responsibilities. Average English skills are expected. Language of instruction is German What we offer you Your education and research benefit from our close partnerships with the University of Natural Resources and Life Sciences, Vienna (BOKU) and the associated Vienna Institute of Biotechnology (VIBT), who share the campus with us, as well as our strong network in the industry. You will learn from experts from biotech companies that play a leading role when it comes to combining Good Manufacturing Practice-oriented quality management with management methods. Practical relevance is also guaranteed at our Campus Lecture evenings, which are open to all and feature contributions from prominent experts.Once you have completed the bachelor's degree program in Bioengineering and the master's degree program in Biotechnological Quality Management, you will be entitled to attend the postgraduate course "Pharmaceutical Quality Management" at the University of Vienna and thus in the future be responsible for the approval of medicinal products. For further information, please visit the secretary's office. What makes this degree program special Good Manufacturing Practice is required in the biopharmaceutical and other industry sectors, and management optimization is the means to implement it.The degree program provides both.While certain regulatory conditions in the biopharmaceutical industry are legally binding and leave little room for economic considerations, companies are focusing more and more on processes that can be optimized and therefore can be carried out more cost-effectively.Management methods such as value stream analysis, operations research or energy-related evaluation are necessary tools when business decisions must be made.With this management know-how, you will be highly sought after. What you will learn in the degree program This program will provide you with extensive QM expertise. In the field of quality management you will learn about a wide variety of norms and regulations: ISO 9001, Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP). You will acquire know-how in company hygiene, risk and safety in microbiology, process analysis and validation, quality control, and products and their production. You will expand your knowledge of bioprocess technology, pharmacology and toxicology. You will study the legal foundations that set the essential standards for quality management. This will also include international guidance documents, documentation and patent law. You will acquire the principles of planning and development including project management and corporate management as well as methods for scientific work. Curriculum 1. Semester LectureSWSECTSTechnical Risk Analysis Practice UETechnical Risk Analysis Practice UELector: Dr. Reinhard Preiss1SWS2ECTSLecture contentsApplication of specialized techniques for risk analyses: Fault Tree Analysis Event Tree Analyses and Layer of Protection Analysis HACCP SWIFT (Structured What-If) Analyses; ChecklistsAssessment methodswritten exam (risk analysis examples)Teaching methodsPresentation of techniques, common acquirement of working examples.LanguageGerman12Parenterals VOParenterals VOLector: O.Univ.-Prof. Mag.pharm. Dr. Helmut Viernstein1SWS2ECTSLecture contentsThe 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 methodswritten examinationTeaching methodslecture12Technical Risk Analysis ILVTechnical Risk Analysis ILVLector: Dr. Reinhard Preiss1SWS2ECTSLecture contentsBasic 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 methodswritten examTeaching methodsPresentation, common acquirement of working examples.LanguageGerman12Bioprocesses and Products VOBioprocesses and Products VOLector: Dr. MMag. Agnes Bugajska-Schretter, Dipl.-Ing. Helga Sgardelli, Dr. Martin Spruth1.5SWS3ECTSLecture contentsThis 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 methodsFinal ExamTeaching methodsLectureLanguageGerman1.53Introduction to GMP and Quality Management VOIntroduction to GMP and Quality Management VOLector: Hon.-Prof. Univ.-Doz. DI Dr. Rudolf Friedrich Bliem1SWS2ECTSLecture contentsTerms, 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 methodsWritten exam + practical exerciseTeaching methodsLecture with discussion HomeworkLanguageGerman12Good Manufacturing Practice, Eudralex ILVGood Manufacturing Practice, Eudralex ILVLector: Frank Kasteliz1SWS2ECTSLecture contentsGood 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 methodsWritten examination (open book exam) at the end of course.Teaching methodsPowerPoint presentation of the content, reading/exertion of the EUDRALEX documents; teamwork and workgroups to learn and understand the most topics in the pharmaceutical industry.LanguageGerman12Immunology VOImmunology VOLector: DI Dr. nat. techn. Matthias Hackl, Dipl.-Ing. Dr. Michael Traxlmayr1SWS2ECTSLecture contentsThe 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 methodsThe 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 methodsLecture/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.LanguageGerman-English12Implementation of Analytical Methods UEImplementation of Analytical Methods UELector: DI(FH) Robert Schwarz, Mag. Helga Weisse1.5SWS2ECTSLecture contentsImplementing an analytical method to practice the validation of analytical methods in depthAssessment methodsinteractive participation Assessment of practical work and authoring of all validation documentsTeaching methodsLectured practicalLanguageGerman1.52ISO 9001 ILVISO 9001 ILVLector: Georg Hochfellner, BSc MSc1.5SWS3ECTSLecture 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 detailAssessment methods- written examTeaching methods- Lecture and exercisesLanguageGerman1.53Physiology VOPhysiology VOLector: Mag. Dr. Oliver Kudlacek, DI Dr. Herwig Moll1SWS2ECTSLecture contentsBasics of Physiology; Cellcycle, immunology, metabolic processes, signal transduction, blood system, heart, autonomous nervous system, central nervous system, receptors and ion-channlesAssessment methodswritten examTeaching methodsLectureLanguageGerman12Validation ILVValidation ILVLector: DI(FH) Robert Schwarz1SWS2ECTSLecture contentsThe 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 methodsConcurrent 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 methodsLecture 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.LanguageGerman-English12QM-System Development ILVQM-System Development ILVLector: Ing. Mag.(FH) Wolfgang Pölz, MSc, MBA1SWS2ECTSLecture contentsCreation 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 methodsActive 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 methodsSeminaristic work, theoretical impulsesLanguageGerman12Selected Subjects in Quality Management and Master Thesis Preparation SESelected Subjects in Quality Management and Master Thesis Preparation SELector: Ing. Mag.(FH) Wolfgang Pölz, MSc, MBA1SWS2ECTSLecture contents.Assessment methodsCourse immanentTeaching methodsLecture and exercises. The Focus lies on Independent Problem solving.12Selected topics in Quality Management VOSelected topics in Quality Management VOLector: Hon.-Prof. Univ.-Doz. DI Dr. Rudolf Friedrich Bliem, Dipl.-Ing. Gerald Holzmann, Bakk. techn.1SWS2ECTSLanguageGerman12 2. Semester LectureSWSECTSExternal and internal auditing VOExternal and internal auditing VO0.5SWS1ECTSLecture contentsThe 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 methodsActive 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 methodsseminaristic work, theoretical impulses0.51Process Modelling and Simulation VO+UEProcess Modelling and Simulation VO+UELector: Ing. Christoph Kogler, BSc MSc, Dipl.-Ing. Martin Pernkopf, BSc2.5SWS5ECTS2.55Specific Statistics Practice UESpecific Statistics Practice UELector: Eva Valerie Lehner, BSc, Dipl.-Ing. Dr. Alexandra Posekany1SWS2ECTS12Biopharmakology VOBiopharmakology VOLector: Mag. Dr. Oliver Kudlacek, Priv.Doz.in Dr.in Dagmar Stoiber-Sakaguchi1.5SWS3ECTS1.53Introduction to Operations Research VOIntroduction to Operations Research VOLector: Mag. Wolfgang Kreiter1SWS2ECTS12Optimization Methods UEOptimization Methods UELector: Dipl.-Ing. Gerald Holzmann, Bakk. techn.1SWS2ECTS12Pharmaceutical Technology VO+UEPharmaceutical Technology VO+UELector: Mag. Theresa Balber, Mag. Dr. Cecile Philippe, Andreas Schirmbrand, Assoc.Prof. Priv.Doz. Mag. Dr. Stefan Tögel, O.Univ.-Prof. Mag.pharm. Dr. Helmut Viernstein2SWS4ECTS24QM in Food Production VOQM in Food Production VOLector: Dr. Martin Hofer, MSc MBA1SWS2ECTS12Six Sigma, Lean, Kaizen VO+UESix Sigma, Lean, Kaizen VO+UELector: Ing. Gerald Berger2SWS4ECTS24Specific Statistics VO+UESpecific Statistics VO+UELector: Dipl.-Ing. Dr. Alexandra Posekany1SWS2ECTS12Behavior and Error Performance SEBehavior and Error Performance SELector: Georg Hochfellner, BSc MSc1SWS2ECTS12 Auditing ILV 0.51 3. Semester LectureSWSECTSAccreditation and Auditing ILVAccreditation and Auditing ILVLector: Dr. Robert Leubolt1SWS2ECTSLecture 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 assessmentsAssessment methods- written examination at the end of the courseTeaching methods- Seminar - individuell work on specific examples in the area of auditingLanguageGerman12Industrial Facility Hygiene VOIndustrial Facility Hygiene VOLector: DI(FH) Robert Schwarz1SWS2ECTSLecture contentsGood 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 methodsWritten Final Exam and continuous progress check (homework, partial tests, ...)Teaching methodsLectured course and blended learningLanguageGerman-English12Biosafety and Biosecurity VOBiosafety and Biosecurity VOLector: Hon.-Prof. Univ.-Doz. DI Dr. Rudolf Friedrich Bliem0.5SWS1ECTSLecture contentsThis 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 methodsFinal ExamTeaching methodsLectured CourseLanguageGerman-English0.51Business Plan and Cost Accounting ILVBusiness Plan and Cost Accounting ILVLector: Mag. Dipl.-Ing. Dr. Martin Pfeffer, Mag. Karin Pfeffer2SWS4ECTSLecture contents"hands-on" priciples in business administration Development of a business planAssessment methodspreparation & presentation of a business planTeaching methodslecture, WorkshopLanguageGerman24Data Mining and Visualization ILVData Mining and Visualization ILVLector: Dipl.-Ing. Barbara Lederer1SWS2ECTSLecture contentsBasic concepts of Data Mining Introduction into Visualization Pros and Cons in representations Practical exercisesAssessment methodsThe examination consists of attendance, active participation as well as the grading of exercise work and presentations.Teaching methodsLecture plus exerciseLanguageGerman12Energy Technology for Quality Management ILVEnergy Technology for Quality Management ILVLector: Univ.-Prof. DI Dr. Herbert Braun1SWS2ECTSLecture contentsFundamentals 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 methodsExaminationTeaching methodslessonsLanguageGerman12Good Clinical Practice and Pharmacovigilance VOGood Clinical Practice and Pharmacovigilance VOLector: Mag. DDr. Alexander Hönel, MSc MBA LLM1SWS2ECTSLecture contentsTo 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 methodsPresentation of the student and their evaluation as assessmentTeaching methodsIntroduction into the topic as lecture, followed by selected topics to be presented by the student on the last day of the lecture.LanguageGerman-English12Quality Control and Quality Assurance in the Laboratory ILVQuality Control and Quality Assurance in the Laboratory ILVLector: Dipl.Ing. Dr. Christine Prenner, Ao.Univ. Prof. DI Dr. Karola Vorauer-Uhl2.5SWS4ECTSLecture contentsThis 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 methods30% presentation 30% homework 40% final, written examination each part need to be positiveTeaching methodsThe 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 plattformLanguageGerman2.54Regulatory Requirements in Drug Licensing ILVRegulatory Requirements in Drug Licensing ILVLector: Mag. Dr. Elke Litzlbauer, DI (FH) Jürgen Waditschatka, DI Dr. Christa Wirthumer-Hoche1.5SWS3ECTSLecture contentsThis 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 methodswritten assignment of the respective task including verbal presentation / questioningTeaching methodsLecture / TutorialLanguageGerman-English1.53Statistical Process Control ILVStatistical Process Control ILVLector: Dr. Moritz Imendörffer1.5SWS3ECTSLecture contentsRegulatory 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 SPCAssessment methodswritten examTeaching methodslecture with excercisesLanguageGerman1.53Materials Stream and Environmental Management ILVMaterials Stream and Environmental Management ILVLector: Mag. Dr. Andreas Franz1SWS2ECTSLecture contentsISO 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 statementAssessment methodswritten exam Presentation of a group work on a given topicTeaching methodsLecture with the help of slides, added with practical examplesLanguageGerman12Sterilization and Disinfection ILVSterilization and Disinfection ILVLector: Hon.-Prof. Univ.-Doz. DI Dr. Rudolf Friedrich Bliem1SWS2ECTSLecture contentsTerms and overview of processes for microbial inactivation Processes of moist heat inactivation, as well as chemical and thermal disinfection Predictive calculation modelsAssessment methodswritten examTeaching methodslectured courseLanguageGerman-English12ISO 45001 and integrated QM VOISO 45001 and integrated QM VOLector: Mag. Dr. Andreas Franz0.5SWS1ECTSLecture contentsThis 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 AustriaAssessment methodsWritten examination, presentation if necessary, online examinations if necessary in accordance with the hygienic requirements.Teaching methodsLecture, group work with presentation according to the possibilities (presence phase, online phase)LanguageGerman0.51 4. Semester LectureSWSECTSMaster Thesis Supervision APMaster Thesis Supervision AP0SWS1ECTSLecture contentsPreparation for the master´s degree examinationAssessment methodsPresentation with assessment of the master´s degree thesis and general examinationTeaching methods-01Master Thesis MTMaster Thesis MT0SWS28ECTSLecture contentsThe content of this course is the writing of a diploma thesis.Assessment methodsThe "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 methodsThe 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.028Master Thesis Seminar SEMaster Thesis Seminar SELector: Dipl.-Ing. Dr. Johanna Hämmerle1SWS1ECTSLecture contentsIn 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 methodsAssessment of the given presentation (structure, slide deck, presentation style, timing).Teaching methodsPresentationLanguageGerman11Semester datesSummer semester 2020: 10th February to 12th July 2020Winter semester 2020/21: 17th August 2020 to 31st January 2021 Number of teaching weeks20 per semesterTimes 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)Language of instruction German Career opportunities As a QM expert you will be qualified to take on responsibility in quality assurance, quality control or validation in the product registration, plant design, auditing and GMP fields. You will find a career in the following occupational fields:Biopharmaceutical industryIndustrial biotechnologyFood industryEnvironmental technology Cosmetic industryPlasmapheresis centersPublic health sector Admission Admission requirements Bachelor degree in natural sciences-technology or similar qualification from an institute of higher education with a total of 180 ECTS creditsWith 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 abroadRegulation for the admission of third country citizensInformation for applicants with non-Austrian (school) certificatesEquivalence is determined by international agreements, validation or in individual cases a decision by the head of the academic section. Application There are 18 places available in the master's degree program in Biotechnology Quality Management each year. The ratio of places to applicants is currently around 1:3. To apply you will require the following documents:Bachelor/diploma certificate or equivalent certificate from abroadCertificates from abroad as well as a description of the courses and exemplary documents must be submitted as certified translations. Letters of recommendation from teachers from the institute abroad will help the head of the academic section to assess whether the admission requirements have been fulfilled.List of courses completed or transcript Letter of motivationCV in table form Please note: It is not possible to save incomplete online applications. You must complete your application in one session. Your application will be valid as soon as you upload all of the required documents and certificates. In the event that some documents (e.g. references) are not available at the time you apply, you may submit these later via email, mail or in person by no later than the start of the degree program. Admission procedure The admission procedure consists of a written test and an interview with the admission committee.AimThe 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.ProcedureThe 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.CriteriaThe 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. Contact > FH-Prof. DI Dr. Michael Maurer Head of Degree Program Bioengineering, Bioinformatics, Biotechnological Quality Management, Bioprocess Engineering T: +43 1 606 68 77-3601michael.maurer@fh-campuswien.ac.at Secretary's office Elisabeth BeckElisabeth Holzmann, Bakk.techn.Johanna BauerBarbara PhilippMuthgasse 621190 ViennaT: +43 1 606 68 77-3600F: +43 1 606 68 77-3609bioengineering@fh-campuswien.ac.atMap Muthgasse (Google Maps)Office hours during semesterMon to Thu, 4.30 p.m.-6.00 p.m. By appointmentMon to Thu, 10.00 a.m.-6.00 p.m.Fri, 10.00 a.m.-1.00 p.m. Teaching staff and research staff > FH-Prof. DI Dr. Michael Maurer Head of Degree Program Bioengineering, Bioinformatics, Biotechnological Quality Management, Bioprocess Engineering Cooperations and Campusnetzwerk We work closely with numerous industrial companies, universities such as the University of Natural Resources and Life Sciences, Vienna (BOKU) and other research institutes. This guarantees you strong contacts for your professional career or participation in research and development activities. You can find information about our cooperation activities and much more at Campusnetzwerk. It’s well worth visiting the site as it may direct you to a new job or interesting event held by our cooperation partners!Campusnetzwerk Downloads and Links Information Biotechnological Quality Management Master (PDF 117 KB)Folder Applied Life Sciences (PDF 1,2 MB)
1. Semester LectureSWSECTSTechnical Risk Analysis Practice UETechnical Risk Analysis Practice UELector: Dr. Reinhard Preiss1SWS2ECTSLecture contentsApplication of specialized techniques for risk analyses: Fault Tree Analysis Event Tree Analyses and Layer of Protection Analysis HACCP SWIFT (Structured What-If) Analyses; ChecklistsAssessment methodswritten exam (risk analysis examples)Teaching methodsPresentation of techniques, common acquirement of working examples.LanguageGerman12Parenterals VOParenterals VOLector: O.Univ.-Prof. Mag.pharm. Dr. Helmut Viernstein1SWS2ECTSLecture contentsThe 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 methodswritten examinationTeaching methodslecture12Technical Risk Analysis ILVTechnical Risk Analysis ILVLector: Dr. Reinhard Preiss1SWS2ECTSLecture contentsBasic 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 methodswritten examTeaching methodsPresentation, common acquirement of working examples.LanguageGerman12Bioprocesses and Products VOBioprocesses and Products VOLector: Dr. MMag. Agnes Bugajska-Schretter, Dipl.-Ing. Helga Sgardelli, Dr. Martin Spruth1.5SWS3ECTSLecture contentsThis 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 methodsFinal ExamTeaching methodsLectureLanguageGerman1.53Introduction to GMP and Quality Management VOIntroduction to GMP and Quality Management VOLector: Hon.-Prof. Univ.-Doz. DI Dr. Rudolf Friedrich Bliem1SWS2ECTSLecture contentsTerms, 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 methodsWritten exam + practical exerciseTeaching methodsLecture with discussion HomeworkLanguageGerman12Good Manufacturing Practice, Eudralex ILVGood Manufacturing Practice, Eudralex ILVLector: Frank Kasteliz1SWS2ECTSLecture contentsGood 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 methodsWritten examination (open book exam) at the end of course.Teaching methodsPowerPoint presentation of the content, reading/exertion of the EUDRALEX documents; teamwork and workgroups to learn and understand the most topics in the pharmaceutical industry.LanguageGerman12Immunology VOImmunology VOLector: DI Dr. nat. techn. Matthias Hackl, Dipl.-Ing. Dr. Michael Traxlmayr1SWS2ECTSLecture contentsThe 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 methodsThe 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 methodsLecture/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.LanguageGerman-English12Implementation of Analytical Methods UEImplementation of Analytical Methods UELector: DI(FH) Robert Schwarz, Mag. Helga Weisse1.5SWS2ECTSLecture contentsImplementing an analytical method to practice the validation of analytical methods in depthAssessment methodsinteractive participation Assessment of practical work and authoring of all validation documentsTeaching methodsLectured practicalLanguageGerman1.52ISO 9001 ILVISO 9001 ILVLector: Georg Hochfellner, BSc MSc1.5SWS3ECTSLecture 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 detailAssessment methods- written examTeaching methods- Lecture and exercisesLanguageGerman1.53Physiology VOPhysiology VOLector: Mag. Dr. Oliver Kudlacek, DI Dr. Herwig Moll1SWS2ECTSLecture contentsBasics of Physiology; Cellcycle, immunology, metabolic processes, signal transduction, blood system, heart, autonomous nervous system, central nervous system, receptors and ion-channlesAssessment methodswritten examTeaching methodsLectureLanguageGerman12Validation ILVValidation ILVLector: DI(FH) Robert Schwarz1SWS2ECTSLecture contentsThe 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 methodsConcurrent 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 methodsLecture 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.LanguageGerman-English12QM-System Development ILVQM-System Development ILVLector: Ing. Mag.(FH) Wolfgang Pölz, MSc, MBA1SWS2ECTSLecture contentsCreation 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 methodsActive 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 methodsSeminaristic work, theoretical impulsesLanguageGerman12Selected Subjects in Quality Management and Master Thesis Preparation SESelected Subjects in Quality Management and Master Thesis Preparation SELector: Ing. Mag.(FH) Wolfgang Pölz, MSc, MBA1SWS2ECTSLecture contents.Assessment methodsCourse immanentTeaching methodsLecture and exercises. The Focus lies on Independent Problem solving.12Selected topics in Quality Management VOSelected topics in Quality Management VOLector: Hon.-Prof. Univ.-Doz. DI Dr. Rudolf Friedrich Bliem, Dipl.-Ing. Gerald Holzmann, Bakk. techn.1SWS2ECTSLanguageGerman12
2. Semester LectureSWSECTSExternal and internal auditing VOExternal and internal auditing VO0.5SWS1ECTSLecture contentsThe 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 methodsActive 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 methodsseminaristic work, theoretical impulses0.51Process Modelling and Simulation VO+UEProcess Modelling and Simulation VO+UELector: Ing. Christoph Kogler, BSc MSc, Dipl.-Ing. Martin Pernkopf, BSc2.5SWS5ECTS2.55Specific Statistics Practice UESpecific Statistics Practice UELector: Eva Valerie Lehner, BSc, Dipl.-Ing. Dr. Alexandra Posekany1SWS2ECTS12Biopharmakology VOBiopharmakology VOLector: Mag. Dr. Oliver Kudlacek, Priv.Doz.in Dr.in Dagmar Stoiber-Sakaguchi1.5SWS3ECTS1.53Introduction to Operations Research VOIntroduction to Operations Research VOLector: Mag. Wolfgang Kreiter1SWS2ECTS12Optimization Methods UEOptimization Methods UELector: Dipl.-Ing. Gerald Holzmann, Bakk. techn.1SWS2ECTS12Pharmaceutical Technology VO+UEPharmaceutical Technology VO+UELector: Mag. Theresa Balber, Mag. Dr. Cecile Philippe, Andreas Schirmbrand, Assoc.Prof. Priv.Doz. Mag. Dr. Stefan Tögel, O.Univ.-Prof. Mag.pharm. Dr. Helmut Viernstein2SWS4ECTS24QM in Food Production VOQM in Food Production VOLector: Dr. Martin Hofer, MSc MBA1SWS2ECTS12Six Sigma, Lean, Kaizen VO+UESix Sigma, Lean, Kaizen VO+UELector: Ing. Gerald Berger2SWS4ECTS24Specific Statistics VO+UESpecific Statistics VO+UELector: Dipl.-Ing. Dr. Alexandra Posekany1SWS2ECTS12Behavior and Error Performance SEBehavior and Error Performance SELector: Georg Hochfellner, BSc MSc1SWS2ECTS12 Auditing ILV 0.51
3. Semester LectureSWSECTSAccreditation and Auditing ILVAccreditation and Auditing ILVLector: Dr. Robert Leubolt1SWS2ECTSLecture 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 assessmentsAssessment methods- written examination at the end of the courseTeaching methods- Seminar - individuell work on specific examples in the area of auditingLanguageGerman12Industrial Facility Hygiene VOIndustrial Facility Hygiene VOLector: DI(FH) Robert Schwarz1SWS2ECTSLecture contentsGood 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 methodsWritten Final Exam and continuous progress check (homework, partial tests, ...)Teaching methodsLectured course and blended learningLanguageGerman-English12Biosafety and Biosecurity VOBiosafety and Biosecurity VOLector: Hon.-Prof. Univ.-Doz. DI Dr. Rudolf Friedrich Bliem0.5SWS1ECTSLecture contentsThis 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 methodsFinal ExamTeaching methodsLectured CourseLanguageGerman-English0.51Business Plan and Cost Accounting ILVBusiness Plan and Cost Accounting ILVLector: Mag. Dipl.-Ing. Dr. Martin Pfeffer, Mag. Karin Pfeffer2SWS4ECTSLecture contents"hands-on" priciples in business administration Development of a business planAssessment methodspreparation & presentation of a business planTeaching methodslecture, WorkshopLanguageGerman24Data Mining and Visualization ILVData Mining and Visualization ILVLector: Dipl.-Ing. Barbara Lederer1SWS2ECTSLecture contentsBasic concepts of Data Mining Introduction into Visualization Pros and Cons in representations Practical exercisesAssessment methodsThe examination consists of attendance, active participation as well as the grading of exercise work and presentations.Teaching methodsLecture plus exerciseLanguageGerman12Energy Technology for Quality Management ILVEnergy Technology for Quality Management ILVLector: Univ.-Prof. DI Dr. Herbert Braun1SWS2ECTSLecture contentsFundamentals 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 methodsExaminationTeaching methodslessonsLanguageGerman12Good Clinical Practice and Pharmacovigilance VOGood Clinical Practice and Pharmacovigilance VOLector: Mag. DDr. Alexander Hönel, MSc MBA LLM1SWS2ECTSLecture contentsTo 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 methodsPresentation of the student and their evaluation as assessmentTeaching methodsIntroduction into the topic as lecture, followed by selected topics to be presented by the student on the last day of the lecture.LanguageGerman-English12Quality Control and Quality Assurance in the Laboratory ILVQuality Control and Quality Assurance in the Laboratory ILVLector: Dipl.Ing. Dr. Christine Prenner, Ao.Univ. Prof. DI Dr. Karola Vorauer-Uhl2.5SWS4ECTSLecture contentsThis 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 methods30% presentation 30% homework 40% final, written examination each part need to be positiveTeaching methodsThe 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 plattformLanguageGerman2.54Regulatory Requirements in Drug Licensing ILVRegulatory Requirements in Drug Licensing ILVLector: Mag. Dr. Elke Litzlbauer, DI (FH) Jürgen Waditschatka, DI Dr. Christa Wirthumer-Hoche1.5SWS3ECTSLecture contentsThis 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 methodswritten assignment of the respective task including verbal presentation / questioningTeaching methodsLecture / TutorialLanguageGerman-English1.53Statistical Process Control ILVStatistical Process Control ILVLector: Dr. Moritz Imendörffer1.5SWS3ECTSLecture contentsRegulatory 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 SPCAssessment methodswritten examTeaching methodslecture with excercisesLanguageGerman1.53Materials Stream and Environmental Management ILVMaterials Stream and Environmental Management ILVLector: Mag. Dr. Andreas Franz1SWS2ECTSLecture contentsISO 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 statementAssessment methodswritten exam Presentation of a group work on a given topicTeaching methodsLecture with the help of slides, added with practical examplesLanguageGerman12Sterilization and Disinfection ILVSterilization and Disinfection ILVLector: Hon.-Prof. Univ.-Doz. DI Dr. Rudolf Friedrich Bliem1SWS2ECTSLecture contentsTerms and overview of processes for microbial inactivation Processes of moist heat inactivation, as well as chemical and thermal disinfection Predictive calculation modelsAssessment methodswritten examTeaching methodslectured courseLanguageGerman-English12ISO 45001 and integrated QM VOISO 45001 and integrated QM VOLector: Mag. Dr. Andreas Franz0.5SWS1ECTSLecture contentsThis 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 AustriaAssessment methodsWritten examination, presentation if necessary, online examinations if necessary in accordance with the hygienic requirements.Teaching methodsLecture, group work with presentation according to the possibilities (presence phase, online phase)LanguageGerman0.51
4. Semester LectureSWSECTSMaster Thesis Supervision APMaster Thesis Supervision AP0SWS1ECTSLecture contentsPreparation for the master´s degree examinationAssessment methodsPresentation with assessment of the master´s degree thesis and general examinationTeaching methods-01Master Thesis MTMaster Thesis MT0SWS28ECTSLecture contentsThe content of this course is the writing of a diploma thesis.Assessment methodsThe "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 methodsThe 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.028Master Thesis Seminar SEMaster Thesis Seminar SELector: Dipl.-Ing. Dr. Johanna Hämmerle1SWS1ECTSLecture contentsIn 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 methodsAssessment of the given presentation (structure, slide deck, presentation style, timing).Teaching methodsPresentationLanguageGerman11
> FH-Prof. DI Dr. Michael Maurer Head of Degree Program Bioengineering, Bioinformatics, Biotechnological Quality Management, Bioprocess Engineering T: +43 1 606 68 77-3601michael.maurer@fh-campuswien.ac.at
> FH-Prof. DI Dr. Michael Maurer Head of Degree Program Bioengineering, Bioinformatics, Biotechnological Quality Management, Bioprocess Engineering