The basics of auditing:

• Definition and importance of audits.
• Different types of audits (internal, external, supplier audit, certification audit).

Regulatory framework conditions:

• Relevant norms and standards (e.g. ISO 9001, ISO 19011).
• Legal requirements and industry-specific regulations.

Audit process:

• Planning and preparation of audits.
• Implementation of audits: Methods and techniques (e.g. document review, interviews, observations).
• Reporting and follow-up of audit findings.

Roles and responsibilities:

• Duties and qualifications of auditors.
• Independence and objectivity in the audit process.

Quality assurance and continuous improvement:

• Use of audits to identify potential for improvement.
• Implementation of corrective and preventive measures.
• Monitoring and evaluation of the effectiveness of measures.

Specific audit types:

• Process audit: Checking the effectiveness and efficiency of individual processes.
• System audit: Evaluation of the entire management system.
• Product audit: Checking product quality and compliance with specifications.
• Compliance audit: Checking compliance with legal and regulatory requirements.

Case studies and practical applications:

• Analysis of real audit examples.

Lecture with structured exercises

Final exam: Final written examination

• - Basics, context and terms of quality management
• - Overview of the ISO 900ff family of standards
• - The requirements of EN ISO 9001:2015 in detail

Lecture with structured exercises

Final exam: Written final examination

Industrial hygiene:

• Good manufacturing practice
• Procedures to avoid harmful contamination
• Specific implementation and tools
• Operational elements

Sterilization and disinfection:

• Terms and concepts of sterilization, pasteurization, disinfection and cleaning
• Principles and correlation of different methods of germ inactivation
• Steam sterilization, chemical and thermal disinfection processes
• Calculation models for sterilization

Biosafety and biosecurity:

• Concepts of biosafety and worker protection in accordance with EN 45001
• Recognition, assessment and treatment of biological hazards in the context of the Austrian Ordinance on Biological Agents
• Biosafety: risk factors, risk classes, practical examples, technical safety measures, legal principles
• Biosecurity: Access security in the microbiological laboratory

Plant cleaning:

• Cleaning of surfaces in contact with the product
• Process and beverage matrices
• Analysis and planning of cleaning validation
• Exercise example for cleaning and cleaning validation, e.g. on a fermentor

Blended learning

Final exam: Intermediate examination (weighting 40%)

Final written examination (weighting 60%)

• Terms, principles, concepts and practice of today's quality management and in particular good manufacturing practice;
• Processes and their procedural instructions;
• Models and standards;
• the concept of "The Deviation" and its general meaning;
• Good manufacturing practice: legal basis and meaning;
• selected aspects of good manufacturing practice.

Lecture with discussion

Final exam: Final written examination

• Contents of EudraLex Vol 4
• Pharmaceutical QM in a GMP company
• Personnel organization in GMP operations
• Premises and equipment
• GMP documentation
• Good manufacturing practice
• Quality control in GMP operations
• non-compliance /warning letter

Lecture with structured exercises

Final exam: Written final exam (open book exam)

• Development of quality control requirements in the pharmaceutical industry
• Organization of control laboratories
• Staff and equipment qualification
• Method validation and transfer
• Pharmacopoeias, reference substances
• Data integrity
• inspections
• Sampling
• Good laboratory practice
• General requirements for active substances and excipients

Lecture with structured exercises

Final exam: Presentations and project work

Written final examination

• The lecture deals with biologically and biotechnologically produced drugs, in particular monoclonal antibodies, vaccines, gene therapy and cellular therapies.
• The basics of drug development from a regulatory and economic perspective as well as the clinical challenges of tolerability and efficacy are discussed.
• A comparison between "patient-tailored" approaches and historical treatments is explained using examples from oncology.
• In-depth examples of innovative therapeutics, such as AAV9-based gene therapy and immune checkpoint inhibitors, provide a comprehensive look at the development and application of these therapies.
• The relevance of genetics and immunology for modern therapeutic approaches and vaccines is outlined to illustrate their practical use.
• Finally, an outlook on career opportunities in the biotech and pharmaceutical industry is given.

Lecture

Final exam: Final written examination

Students learn the in-depth use of R for the analysis and visualization of data that may arise in biopharmaceutical processes.

• Programming with R
• Process and methods of data analysis
• Multivariate analysis
• Factors and cluster analysis
• Multiple regression analysis
• Logistic analysis
• Graphical forms of representation of complex statistical data sets
• Quality tools
• Special packages for data analysis
• Visualization methods and packages
• Analysis methods with AI

Lecture with interactive exercises

Continuous assessment: Submission of project work

The course deals with statistical topics in the context of biostatistics:

Exploratory data analysis
Fundamentals of statistical inference (hypothesis testing)
Statistical modeling, model selection

• Non-linear functions; applying scale transformations to linearize non-linear dependencies;
• distributions: In-depth: Normal, Poisson, binomial; log and gamma distribution; checking the normal distribution assumption (QQ plot, Shapiro-Wilk test); identifying outliers (Grubbs test);
• Parameters: Mean, median, variance; measures of location, dispersion and shape;
• Multivariate analysis; factors and cluster analysis; logistic analysis;
• Statistical tolerancing: calculation of measurement chains and basics of statistical tolerancing;
• Discussion of the error concept: dispersion, minimization, implementation in device tolerance, limit value and alarm value, sampling statistics and legal sampling plans, e.g. testing for sterility according to the pharmacopoeia
• Sampling: Calculating samples: being able to describe 1- and 2-dimensional samples with dimensional figures and graphs; planning minimum sample sizes to determine relevant deviations for simple alternative tests

Lecture with interactive exercises

Continuous assessment: immanent performance assessment (homework, cooperation, final written examination)

The topics from the Special Statistics course are consolidated using practical examples. Students are taught how to select the right methods for specific questions. They will work with the statistical software "R" (freeware).

Lecture with interactive exercises

Continuous assessment: Immanent performance review (homework, final exam)

• Logic and aim of statistical comparative studies
• elementary evaluative statistics
• basic experimental designs
• errors in the statistical assessment of data
• required sample size
• Interpretation of P-value
• coefficient of determination and residual error
• elementary variance analysis methods, ANOVA, regression, etc.

Lecture with interactive exercises

Final exam: Partial performance and final written examination

Introduction to academic writing with AI

• Definition and importance of scientific writing
• Overview of AI-supported tools and technologies
• Advantages and challenges of using AI in academic writing

Formulation and writing process

• Use of AI to generate text suggestions and formulations
• Support in the creation of clear and precise scientific texts
• Automated translation and paraphrasing services
• Plagiarism checking and ensuring scientific integrity
• Legal framework and data protection
• Ensuring academic integrity and avoiding plagiarism
• Best practices and tips for integrating AI tools into the writing process
• Reflecting on and continuously improving your own writing skills with the support of AI

Lecture with structured exercises

Continuous assessment: Homework

• Quality management in product development;
• interaction of technology, key figures and networking in the context of  quality management based on practical examples;
• reduction of waste, personnel and equipment overload and process fluctuations in the value chain, combined with continuous improvement;
• forms and practical examples of Six Sigma, Kaizen and Lean

Lecture with structured exercises

Final exam: Final written examination

Process management and optimization

• Process analysis and design: Methods for analyzing and designing processes.
• Continuous improvement: principles and methods such as Kaizen and the PDCA cycle.
• Lean management: basics and application in process optimization.

Quality tools and techniques

• Seven quality tools: flow chart, cause-effect diagram, histogram, Pareto diagram, control chart, scatter diagram and check sheet.
• Failure mode and effects analysis (FMEA): implementation and benefits.

Quality testing and assurance

• Testing methods and techniques: Non-destructive testing, random testing.

Quality management in practice

• Case studies: Analysis and discussion of real case studies.
• Practical examples: Processing of case studies.

Management and communication

• Communication: Effective communication of quality management issues.
• Training and awareness: Development and implementation of training programs.

Lecture with structured exercises

Continuous assessment: Homework

Basics of risk management:

• Terms relating to risk analysis;
• Typical areas of application and special legal aspects
• Cases of damage from the process industry;
• Risk assessment (qualitative, semi-quantitative, quantitative)

Methods:

• FMEA
• HAZOP
• Fault tree analysis (basics)

Application of special risk analysis methods:

• Fault tree analysis
• Event tree analysis and layer of protection analysis
• HACCP
• SWIFT (Structured What-If) Analysis, checklists

Blended learning

Final exam: Final written examination

• Basics of validation
• Regulatory requirements and guidelines
• Device and system qualification (DQ, IQ, OQ, PQ)
• Risk analysis
• Method validation
• Process validation
• Cleaning and sterilization validation
• Validation management and documentation

Blended learning

Continuous assessment: Blended learning tasks

Written final exam

Introduction to self-inspection:

• Definition and objectives of self-inspection
• Importance of self-inspection in quality management

Regulatory requirements:

• Overview of relevant regulations and legal requirements
• EUDRALEX and other relevant directives

Planning and preparation:

• Definition of inspection fields and content
• Scheduling and preparation of an annual plan
• Selection and qualification of inspectors

Carrying out the self-inspection:

• Procedure of a self-inspection
• Inspection methods and techniques
• Documentation of the inspection results

Identification and analysis of non-conformities:

• Recognition and classification of non-conformities
• Root cause analysis and development of corrective measures

Preparation of the inspection report:

• Structure and content of an inspection report
• Communication of results and follow-up measures

Monitoring and continuous improvement:

• Implementation of corrective and preventive actions (CAPA)
• Evaluation of the effectiveness of measures
• Use of self-inspection for continuous improvement of the quality system

Practical exercises and case studies:

• Conducting simulated self-inspections
• Analysis of case studies and best practices

Lecture with structured exercises (carrying out simulation inspections)

Continuous assessment: Immanent performance assessment during the lecture

The course deals with procedures for the production of parenteral preparations and methods for their quality control in accordance with the provisions of the European Pharmacopoeia and international pharmacopoeias. Conventional products as well as innovative developments in the pharmaceutical market are discussed and biopharmaceutical aspects are explained.

Lecture

Final exam: written examination

• General principles of pharmacology
• Pharmacokinetics and pharmacodynamics
• Mechanisms of action of drugs

Lecture

Final exam: Written examination

In-depth knowledge on the subject of clinical trials:

• What is a human trial and what is its legal basis?
• How is the clinical trial positioned in the product life cycle?
• What are the phases of clinical trials and what are the risks?
• Quality assurance measures and current requirements from changing legislation.

Lecture with structured exercises

Continuous assessment: Course immanent to examination, presentation as an essential part of the assessment

• regulatory requirements in the EU
• Authorization procedures for biotechnological products
• Practical development of the most important pharmaceutical compliance aspects

Lecture with structured exercises

Final exam: Written elaboration of the assigned task including presentation with subsequent questioning.

- Statistical principles for the creation and evaluation of quality control charts with exercises

- Statistical basics and discussion of the error concept: scattering, minimization, implementation in device tolerance, limit value and alarm value, sampling statistics and legal sampling plans (e.g. sterility testing)
- Statistical significance of limited sample size
- Special emphasis on the scattering of processes from the control value (inherent "error" and tolerance).

Lecture with interactive exercises

Continuous assessment: immanent performance assessment by means of exercises in the course

• Practical business management concepts
• Development of a business plan
• Practical application of principles of business administration and cost accounting

Blended learning

Continuous assessment: preparation & presentation of a business plan

• Basic principles and framework conditions
• Risk management and risk assessment
• Environmental management
• Occupational health and safety
• Communication
• Project work and practical relevance

Lecture

Final exam: Final written examination

• Communication techniques in management:

  • Basics of target-oriented communication
  • Needs-oriented communication with different stakeholders
  • Methods of professional communication

• Moderation techniques:

  • Moderation of decision-making processes
  • Use of moderation tools in interdisciplinary teams
  • Designing and leading effective meetings

• Conflict resolution:

  • Analysis and diagnosis of conflict situations
  • Development of sustainable conflict resolution strategies
  • Mediation and conflict moderation techniques

• Reporting and presentation:

  • Preparation of structured and addressee-oriented reports
  • Presentation techniques for different target groups
  • Visualization and communication of results

Blended learning

Continuous assessment: Immanent performance test

The basics of self-coaching as well as stress and time management techniques are taught, which are specifically geared towards the requirements of team leadership. Personal perception and communication patterns are analyzed in order to understand their impact on team leadership and interaction with team members. Participants try out methods for self-motivation, reflect on strategies for promoting resilience and develop approaches for implementing effective time management in team leadership. Practical exercises and implementation tasks enable the application and consolidation of self-management skills, which are essential for professional team leadership in everyday working life.

Main topics:

• Self-coaching and self-motivation for managers
• Stress and time management in team leadership
• Perception and interpretation in everyday leadership
• Communication analysis and its importance for team leadership

Activating methods

Continuous assessment: Immanent performance review

The course "Fundamentals of Operations Research"
- provides a general insight into the basic ideas and tasks of Operations Research.

- deals with selected OR methods such as linear optimization and combinatorial optimization by explaining the procedures in more detail and practicing simple examples.

- explains other OR methods such as queueing theory, game theory, graph theory and simulation

- gives an impression of the theory and practice of various decision procedures

- provides the basics of stochastics in general and probability distributions in particular

The course "Fundamentals of Operations Research" is designed as a combination of theoretical lectures and exercises.

Final exam: The course is assessed by the final written test (100% of the points).

Additional points can be earned through participation in class and in the revision exercises at the beginning of the following lesson.

The content ranges from general terms and definitions of project management to project development, project planning, implementation and control through to project completion.

• General terms and basics: definition of project and project management, differences between project/process, when does a task become a project, overview of project types, pros/cons of projects, organizational forms and project phase
• Project initialization: principles of idea development, from the idea to the project assignment (project charter), team formation and development, stakeholder analysis, governance
• Project planning: basics, task planning, process planning, scheduling, cost and resource planning, risk management
• Project implementation and control: basics of monitoring and control (deadlines, costs, performance, risk), project reporting,
• Project completion: handover of results, final analysis, lessons learned, project team dissolution

Blended learning

Continuous assessment: Immanent performance assessment by means of project work

This course provides a practical introduction to the modeling (Module 1: BPM, Module 2: BPR) and simulation (Module 3: DES, Module 4: ABS/SD) of processes. 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)

The flipped classroom concept combines online teaching and self-study units to provide a practical introduction to process modeling (BPM, BPR) and simulation (DES, ABS, SD). Application examples, case studies and tutorials with Bee-Up and AnyLogic are implemented and analyzed. Zoom units clarify questions and integrate interactive elements, while Moodle-based self-study units convey content flexibly and individually. Supporting materials such as simulation examples, screencasts, learning questions, tutorials and a script supplement the teaching.

Continuous assessment: Immanent performance assessment through, among other things: Collaboration, assignments, tests, challenges, group work, presentations, exercises

• Further development and elaboration of the research design in the form of an exposé for the Master's thesis
•  
• The Master's thesis must meet the requirements of a scientific or engineering thesis.
• The data collection is primarily experimental

research methodology:

The research methods used to complete the tasks and answer the questions are listed here.

The status of the methods (existing expertise): Which methods are already in place and which need to be established or even developed in the course of the work?

A series of studies should always be carried out on the basis of written methods and an experimental plan drawn up in advance. The results are continuously summarized in partial reports during the course of the project.

Literature research:

Examination of the latest scientific findings, technical developments and the current state of knowledge in the field of work.

Elaboration of a theme paper

Continuous assessment: Topic of the Master's thesis

Basics of computer validation:

• Definition and importance of computer validation in regulated industries.
• Overview of relevant regulatory requirements and guidelines (e.g. FDA, EMA, GAMP5).

Validation process:

• Planning and implementation of validation projects.
• Creation and implementation of validation plans (Validation Master Plan, VMP).
• Risk analysis and risk management in the context of computer validation.

Documentation and verification management:

• Creation and maintenance of validation documents (e.g. URS, FRS, IQ, OQ, PQ).
• Importance of documentation for traceability and compliance.

Technical aspects of validation:

• Validation of software and computer systems.
• Test methods and test strategies (e.g. black-box testing, white-box testing).
• Data integrity and security requirements.

Quality assurance and continuous improvement:

• Monitoring and maintenance of validated systems.
• Implementation of revalidations and change management.
• Audits and inspections in the context of computer validation.

Case studies and practical applications:

• Analysis of real validation projects.
• Discussion of challenges and best practices.

Lecture

Final exam: Final written examination

• Basics of entrepreneurship
• Current challenges in the start-up sector
• Generating ideas
• Entrepreneurial spirit: forming start-up teams
• Elements of founding a company/building a start-up
• Error culture
• Pitch preparation

Blended learning

Project work in teams

Continuous assessment: Final presentation of the project work (pitches)

• Instructions and presentation of the Master's thesis with discussion on the planning, design, implementation, documentation and presentation of scientific or engineering work.
• Practice of the presentation to be given as part of the Master's examination
• What is particularly important when presenting a scientific paper?
• Receiving & giving feedback.

Presentations, discussion of a scientific article

Continuous assessment: Assessment of the given presentation (structure, slide deck, presentation style, timing).

The content of this course is the writing of a Master's thesis.

Many students develop Master's thesis topics, conduct research and write their Master's thesis in cooperation with or at the suggestion of companies. Around 20% find a topic with the help of their lecturers or supervisors.

The Master's thesis must be written in consultation with the UAS supervisor and after approval by the head of the degree program.

Continuous assessment: Assessment of the written Master's thesis according to a standardized catalog.

Examination interview on study-relevant content.

Self-study

Final exam: Presentation with assessment of the master´s degree thesis and general examination.