790030 Technology and innovation management in biotech (in Eng.)


Art
Vorlesung
Semesterstunden
1.5
Vortragende/r (Mitwirkende/r)
Pohlscheidt, Michael , Egger, Dominik , Kasper, Cornelia
Organisation
Angeboten im Semester
Sommersemester 2022
Unterrichts-/ Lehrsprachen
Englisch

Lehrinhalt

Technology Transfer, Equipment Characterization and Scale Up: Basic principles, risk management, facility fit /process adaptations, regulatory perspectives, business aspects, Basic scale up principles equipment characterization, tools for trouble shooting and risk mitigation, practical examples of upstream and downstream steps
Introducing New Technologies and Existing Processes: Selected principles of technology & innovation management, technology roadmaps organizational aspects, change management, statistical process control and data analysis
Regulatory and Quality Aspects: Regulatory agencies, current guidelines, QA/ QC aspects, risk management, IPC control product characterizations, process validation and Quality by design
Operational Excellence and Supply Chain Management Aspects: Challenges in manufacturing, Basics of business process management, operational excellence, problem solving approaches (DMAIC), From development to launch; supply chain examples and risk mitigations, facility utilization, challenges in the pharmaceutical industry

Inhaltliche Voraussetzungen (erwartete Kenntnisse)

Study courses of Biochemical Engineering, Biotechnology or similar (minimum MSc level)
Doctoral student can participate if course selection is officially accepted by doctoral study office! Please note that no exeptances will be offered!

Lehrziel

Participants receive insight into Technology and Biotech Manufacturing Process Lifecycle Management in the Pharmaceutical Industry. Based on lectures they will understand specific topics of biotech industry including tech transfers, general principles, characterization methods including regulatory, technical, quality and business perspectives. Case studies simulating “real industry life” will enable students to obtain an end to end view on commercial manufacturing, challenges and current practices incl. quality, regulatory, business and innovation aspects. Taken together, student will be able to apply the basic principles and interactions of quality, business process management, operational excellence, technology management and supply chain management
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