SAS Dig­i­tal Project Tools & CAPEX Man­age­ment in Biotech, FHNW School of Life Sciences

Develop the practical skills needed to successfully plan, execute, monitor and close pharmaceutical projects.

After completing the SAS, you will be able to:

• Learn how to structure and manage projects using work breakdown structures
• Get in-depth knowledge of digital tools and software used in modern project management
• Understand the fundamentals of CAPEX projects
• Enlarge your know-how in procurement, supply chain coordination and resource planning
• Understand ne equipment introduction processes, including commissioning validation and IQ/OQ/PQ activities

This SAS is for you if you are currently working as a project manager in a pharmaceutical company, aspiring to enter a project management role within the pharmaceutical industry, or working in R&D, regulatory affairs or quality assurance management.

This SAS is the third of four modules in the CAS Pharmaceutical Project Management. It is offered onsite over four days.

The main learning outcome is how to plan, manage, and execute biotech CAPEX projects effectively, using structured project methods, digital tools and validated equipment implementation processes.

The following topics are also covered:

• Work breakdown structure (WBS)
• Agile, waterfall and hybrid approaches
• Project management tools and software
• Introduction to a CAPEX project in Biotech
• Roles and responsibilities of project team members (RACI) and other stakeholders
• Supply chain: procurement, ordering equipment & materials
• User requirement specification / statement of work
• Resource planning: materials, equipment and individuals
• Introduction of new equipment, IQ/OQ/PQ, validation/verification, commissioning

At the end of the module, a multiple-choice test (pass/fail) is available, if you would like to receive ECTS credits. The module can be allocated to the CAS Pharmaceutical Project Management within three years. If you have successfully completed all the SAS in this Certificate of Advanced Studies (CAS) programme and wish to receive the certificate, please contact us for the final written assignment.

• Dr. Kurt Eyer, Industrial Biosolutions, Bühler AG
• René Marty Ph.D. PMP, Senior RnD Program Manager, GALDERMA SA.

The following programme admission requirements apply:

• Tertiary A: Higher education qualification (at least a Bachelor’s degree) and at least 2 years’ practical experience relevant to the programme
• Tertiary B: Colleges of Higher Education Diploma (HF), Advanced Federal Diploma of Higher Education (HFP) or Federal Diploma Higher Education (BP), and at least 5 years’ practical experience relevant to the programme
• Individuals without a Tertiary A or B qualification may be admitted if they cumulatively meet the following admission criteria:
• at least 10 years’ professional experience in a field relevant to the programme, of which at least 5 years in a managerial or senior specialist role
• additional qualifications (various non-formal, extensive further training courses or partial completion (>50%) of a tertiary qualification)
• evidence of knowledge of academic work or a willingness to acquire this in advance