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.

• Students know the key aspects of auditing and can explain the role and responsibility of auditors in different contexts. They are able to plan, participate in and document audit processes

• Students can distinguish between the different types of audits and explain their importance in quality management.

• Students understand the role and importance of authorities in the context of quality management and audits. They can interpret the legal and regulatory requirements imposed by authorities and ensure their implementation in practice.

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

• Students will be able to understand the structure and requirements of the ISO 900ff family of standards and explain the chapters of ISO 9001 in detail.

• Students can apply these ISO standards in various professional contexts and are able to develop and implement strategies to significantly improve organizational performance.

• Students are able to design innovative approaches to quality improvement in organizations and monitor their implementation.

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

• Students understand the definition of hygiene in the context of industrial hygiene and the pharmaceutical industry. They are able to understand hygiene as an interdisciplinary topic relating to the areas of personnel, buildings, materials, methods and equipment and can evaluate, delimit and describe the associated processes.

• The students acquire theoretical knowledge of germ inactivation, in particular inactivation using moist heat. The students can explain, interpret and characterize germ inactivation.

• Students can interpret, differentiate and evaluate the concepts of biological safety (containment and biosafety). They can interpret the legal regulations applied in Austria and are able to identify the corresponding requirements for microbiological work.

• Students will be able to apply, analyze, plan, evaluate and assess regulatory knowledge of the cleaning of surfaces in fermentation plants used in the biopharmaceutical industry which are in contact with the product.

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.

• Students know the basic concepts of pharmaceutical quality management and understand their significance in the context of GMP. They are able to identify the associated standards and explain their application in practice.

• After completing the course, students will be able to critically evaluate the relevance and application of GMP concepts and pharmaceutical QM concepts in various industrial contexts.

• Students will be able to implement specific GMP requirements in various industrial contexts in order to initiate continuous improvement processes.

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

• After completing the course, students will be able to understand the minimum requirements of the European Commission's Good Manufacturing Practice and explain their significance for the manufacture of medicinal products. They will be able to apply the principles of GMP to ensure that medicinal products are of the highest quality and user safety.

• Students are familiar with the key concepts of quality management and can implement these within the framework of good manufacturing practice (GMP). They are able to ensure compliance with GMP standards and monitor the manufacturing processes accordingly.

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

• After completing this course, students have theoretical and practical knowledge of quality control of biopharmaceuticals and are able to implement and apply this knowledge in practice.

• Students have knowledge of the interpretation of the requirements of European Good Manufacturing Practice for quality control laboratories, particularly in the field of biotechnology.

• Students understand the importance of data integrity in quality control and can implement measures to ensure data integrity. They are also able to prepare and participate in inspections.

• Students know the principles of method validation and method transfer and are able to implement these in practice. They are able to understand and apply the requirements of pharmacopoeias and the use of reference substances.

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.

• Students have the basic knowledge of materials and product quality, production technologies, medical applications and general challenges required for the manufacture of pharmaceuticals and, in particular, biopharmaceuticals.

• Students are able to demonstrate the complexity of innovative therapeutic approaches from molecular discovery in the laboratory to application in patients based on the latest publications and "beyond textbook knowledge".

• Students will be able to critically evaluate the development and application of biologically and biotechnologically produced drugs by analyzing regulatory, economic and clinical aspects, comparing innovative therapeutic approaches with historical treatments and explaining the relevance of genetics and immunology for modern therapies.

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

• Students are able to analyze complex biopharmaceutical data with R.

• Students are familiar with visualization methods, can visualize their data in a meaningful way and are able to use the visualizations to support decision-making processes.

• Students have dealt with the use of artificial intelligence in data analysis and are able to apply multivariate analysis techniques to interpret complex data sets.

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

• After completing the course, students will be able to apply advanced statistical methods in the context of quality management and will be able to solve typical standard tasks in the field independently. They use case studies and analytical methods to answer complex statistical questions and prepare themselves for advanced courses on statistical process control and multivariate data analysis. You will develop a critical understanding of the application and interpretation of statistical methods in practical scenarios.

• Students master the application of non-linear functions and scale transformations for the linearization of non-linear dependencies. They can interpret the results of these transformations and apply them in biostatistical analyses.

• Students are able to calculate samples and describe 1- and 2-dimensional samples using measures and graphics. They can plan 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).

• Students are able to apply exploratory data analysis and statistical modeling to examine complex data structures, test hypotheses and select suitable models.

• Students are proficient in the use of the statistical software "R" and can use it to analyse and visualize data. They are able to carry out complex statistical analyses independently with "R" and interpret the results.

• They can check distributions, calculate parameters and apply multivariate analysis methods such as factor and cluster analysis. They are also proficient in statistical tolerancing and the calculation and evaluation of samples for various test procedures.

• Students are able to carry out statistical analyses independently using case studies and present the results. They are able to apply the methods they have learned to new and unfamiliar questions

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.

• Students are able to plan, organize and evaluate basic statistical comparative studies. They can evaluate practical issues from quality-relevant processes, such as process optimization, process validation or process transfer, using the correct statistical methods.

• Students interpret the results of statistical evaluations and can present these results to stakeholders (non-statisticians) in an understandable way.

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

• Students are able to understand and apply the principles and methods of academic writing. They can use the support of artificial intelligence (AI) to optimize their writing processes and improve the quality of their academic work.

• Students can use AI effectively to support the research, structuring, formulation and revision of scientific texts.

• Students understand the potential and limitations of AI in academic writing and can critically evaluate in which areas the use of AI makes sense. They are able to continuously develop their own writing skills and make targeted use of AI support to improve their academic work.

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

• Students are able to record processes and material flows in order to optimize them economically.

• Students are able to recognize the synergies between Lean, Six Sigma and Kaizen and apply these methods in an integrated manner to improve the overall performance of organizations. They will be able to manage process optimization projects and sustain the improvements achieved.

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.

• Students can apply standards and regulations according to the principles of good manufacturing practice to the biotechnological process. Furthermore, students are able to create, check and maintain quality assurance documents in the production process.

• Students will be able to use quality tools and statistical process control (SPC) to monitor and improve process quality, communicate complex quality management topics in an understandable way and conduct training courses for various target groups.

• Students are able to critically scrutinize and continuously improve their own quality management practices. Students are able to plan and implement quality management projects independently, taking ethical and social aspects into account.

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

• The students know the basics and objectives of risk management and are able to define the concept of risk and the relevant terminology, as well as assess risk analysis methods and identify their strengths and weaknesses. They will also be able to select suitable methods for their future tasks in terms of suitability, effort and costs/benefits.

• Students can apply the methods mentioned to practical problems. Students can select the appropriate methods for the respective tasks with regard to suitability, effort and costs/benefits.

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

• The students understand the basic principles of qualification and validation. This includes the planning phase, device qualification, validation of analytical methods, process validation as well as cleaning and sterilization validation.

• Students have acquired knowledge of validation documentation, such as the master validation plan and validation regulations and reports.

• Students are able to plan and manage validation projects and are proficient in the practical implementation of validation projects (device qualification, cleaning validation, sterilization validation).

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

• After completing the course, students will understand the importance of self-inspection in GMP operations and will be able to explain it. Students will also be able to explain the importance of self-inspection for continuous improvement and compliance with quality standards.

• Students understand the methods for identifying and analyzing non-conformities during a self-inspection. They can develop and implement suitable corrective and preventive measures to ensure the quality and safety of processes.

• Students are able to prepare inspection reports in accordance with the applicable regulations. They can document the results of the inspection clearly and precisely and derive appropriate recommendations for action.

• Students can implement monitoring processes and ensure that all measures to comply with quality standards are effective.

Lecture with structured exercises (carrying out simulation inspections)

Continuous assessment: written exam

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.

• Students have the necessary theoretical and practical basic knowledge of materials and product quality as well as equipment and production technology for the manufacture of pharmaceuticals, in particular biopharmaceuticals.

Lecture

Final exam: written examination

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

• After completing the course, students have a basic knowledge of the functional anatomy, absorption, distribution, metabolism and excretion of drugs, as well as the principles of action and possible side effects of biopharmaceuticals, in particular of recombinant approved products.

• Students understand the pharmacological approaches and have a sound understanding of the effects of active substances on the body (pharmacodynamics) and the influence of the body on the active substances (pharmacokinetics).

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.

• Students understand the role of clinical trials in the product life cycle and can explain their importance for the development and approval of new products.

• Students are able to analyze current requirements and changes in the legal framework and assess their impact on clinical trials.

• After completing the course, students will know the requirements that define a human experiment and will be able to explain the legal basis that regulates such human experiments.

Lecture with structured exercises

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

• Basic and current regulatory requirements within the EU 
• Approval procedures for biotechnologically produced medicines 
• In-depth practical examination of the most important aspects of pharmaceutical compliance

• Students understand the European regulatory requirements for the approval of biotechnological products. They can identify and practically apply the most important pharmaceutical compliance aspects.

• After completing the course, students will have specific knowledge of regulatory requirements to ensure compliance and quality assurance measures.

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).

• Students are able to create and evaluate quality control charts in order to monitor and improve process quality. They can apply statistical methods to analyze the stability and performance of processes.

• Students understand the basics of the error concept, including the scattering and minimization of errors. They are able to put these concepts into practice in order to define device tolerances, limit values and alarm values.

• Students can apply sampling statistics and interpret and implement legal sampling plans, e.g. sterility testing. They are able to take statistical requirements and legal specifications into account when taking samples.

• Students will be able to analyze process variation and the inherent errors associated with it. They can define tolerances and develop measures to minimize process variation

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

• Students will be able to explain basic business concepts and interrelationships and understand their significance for companies.

• Students can apply various business management models and methods to analyze business management problems and develop solutions.

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

• Students are able to identify and apply national and international environmental, health and safety regulations.

• Students will be able to design and implement comprehensive EHS programs based on scientific evidence.

• Students can communicate complex EHS topics in an understandable way and conduct training courses for different target groups.

• Students are able to plan and implement EHS projects independently, taking ethical and social aspects into account.

Lecture

Final exam: Final written examination

Leadership in Complex and Dynamic Organizations

• Development from Specialist to Reflective Leader
• Modern Leadership Concepts and Responsible Leadership
• Self-Leadership, Resilience, and Value-Driven Action
• Developing a Personal Leadership Vision and a Clear Understanding of Leadership

Shaping Communication and Collaboration

• Professional communication as a leadership tool
• Feedback, conversation, and negotiation skills
• Fostering trust, collaboration, and team cohesion
• Values, visions, and corporate culture as the foundation of successful leadership

Successfully Leading and Developing Teams

• Strategic Team Leadership in Interdisciplinary Contexts
• Leadership Styles, Positive Leadership, and Agile Leadership
• Motivation, Emotional Intelligence, and Personality Models
• Team Development, Recruiting, and Employee Development

Managing Change and Innovation

• Conflict Management and Constructive Solution Strategies
• Leadership in Change Processes (Change Management)
• Productivity, Effectiveness, and Decision-Making in Everyday Leadership
• Developing and Implementing Innovative Solutions in Dynamic Work Environments

• Graduates are able to take on leadership tasks in complex and interdisciplinary contexts. They develop and implement strategic approaches to team leadership, promote cooperation and communication within organizations and effectively manage change processes. They reflect critically on their leadership decisions, act responsibly in dealing with various stakeholders and use modern leadership methods to develop and implement innovative solutions in dynamic working environments.

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

• Graduates are able to analyze their own leadership behavior using scientifically based self-coaching methods, to develop it in a targeted manner, and to effectively use strategies for self-motivation as well as stress and resilience promotion in their everyday leadership. They identify individual perception and communication patterns, evaluate their impact on team processes, and use professional communication and moderation techniques to constructively shape complex situations in team leadership. Furthermore, they develop a requirement-based time and priority management, make thoughtful decisions in dynamic contexts and take responsibility for efficient, target-oriented and solution-oriented communication when dealing with teams and stakeholders.

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

• Students are able to systematically analyze complex production and logistics processes as well as material flows. They apply advanced operations research concepts and simulation methods in order to optimize these processes economically.

• By using specialized optimization techniques and programs, students are able to implement sustainable solutions that increase operational efficiency. Students are able to take responsibility for strategic implementation in demanding logistics contexts.

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

• Students are able to manage projects independently and in a structured manner, from initiation through planning and implementation to completion. They apply sound project management methods to define, plan and implement complex project tasks.

• After completing this course, students will be able to analyze and critically evaluate the relevant project management data and communicate it to stakeholders accordingly.

• Students have specific knowledge of the correct documentation and evaluation of project results, derive potential for improvement for future projects and assume responsibility for leading interdisciplinary project teams in dynamic contexts.

• Students can gain an overview of the relevant resources, costs and risks and are able to monitor project progress using effective management and control instruments.

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)

• Students are able to independently model complex processes, apply suitable simulation techniques and systematically analyze the results. They apply well-founded methods to record and optimize complex process chains and develop innovative approaches to increase efficiency.

• Students are able to critically evaluate modeling results, integrate interdisciplinary perspectives and take responsibility for strategic decisions in the context of process design.

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.

• Students demonstrate their ability to systematically investigate an issue, work on a problem in depth using scientific methods and procedures, draw conclusions and describe them in a written paper.

• The Master's thesis demonstrates the student's ability to work on a research question independently and adequately in terms of content and methodology and to derive new findings.

• Students routinely apply techniques of critical and self-regulated reading and writing. Students reflect on the research methodological approaches used in the context of the research question and the intended research objectives.

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.

• Students will be able to explain the importance and regulatory requirements of computer validation in regulated industries. They will be able to plan and carry out validation projects, including the performance of risk analyses.

• After completing the course, students will be able to create, check and maintain validation documents and explain their importance for traceability and compliance.

• Students understand the methods for validating software and computer systems and can apply various test methods and strategies.

• Students are able to explain and carry out revalidations and periodic reviews and implement the corresponding change management.

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

• Students are familiar with terms from the field of entrepreneurship and idea generation and can apply the associated tools theoretically and practically.

• Students are able to carry out the first steps of founding a start-up from the beginning to the presentation of the business idea in the form of a pitch.

• Students can recognize and apply team structures.

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.

• After completing this course, students will be able to effectively summarize and present their Master's thesis. They know the basics of presentation structure, presentation of results, presentation style and adherence to time limits.

• At the end of the lecture students are able to evaluate a scientific topic.

• At the end of the lecture students are able to evaluate a scientific topic.

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.

• Students can write an academic thesis at Master's level.

• Students work independently on scientific research questions and choose appropriate methods to derive new findings.

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.

• Students demonstrate their cross-linked knowledge of biotechnology in an examination discussion on the Master's thesis and course-related content.

• Students will be able to present projects.

Self-study

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