SAS Pharmaceutical Project Management

The course is primarily aimed at project managers and/or staff within project management teams, but also at contract managers, department heads, officials, and functional managers who work in pharmaceutical production facilities and wish to enhance and consolidate their project management skills in accordance with GMP quality standards.

The course is also aimed at those who have been working for years in other roles within pharmaceutical plants and who wish to pursue a career as a Project Manager in the pharmaceutical sector, thus acquiring all the skills that this position requires.

Those who have obtained a Bachelor's or Master's degree from a university of applied sciences and arts or a university, or from a university of teacher education, and who have proven professional experience in fields related to the courses are eligible for admission to Advanced Studies continuing education courses.
Other suitable candidates may also be admitted, in particular those with a higher vocational education and training qualification. These candidates must also have proven professional experience in a field related to the continuing education program and possess adequate scientific knowledge.
Individuals without a tertiary degree, university diploma, or higher vocational education diploma may be admitted on an exceptional basis through a dossier evaluation procedure.

- Lead cross-functional teams using situational leadership and effective communication.
- Identify, assess, and mitigate regulatory, operational, and quality risks.
- Analyze complex project scenarios and propose compliant, sustainable solutions.

Module 1: Fundamentals of Project Management in the Pharmaceutical Sector
Content
- Sector overview and emerging trends
- PM principles and ISO 21502
- Project lifecycle and process groups
- Agile, Waterfall, and Hybrid approaches
- GMP, GxP, FDA/EMA regulatory context

Objectives
- Understand PM fundamentals in regulated environments.
- Identify appropriate PM approaches for different project types.

Activities
- Instructor-led discussion on project types.
- Introduction to the course reference project.

Module 2: Regulatory Affairs, Quality & Compliance
Content
- EMA, FDA, PMDA, MHRA, Swissmedic comparison
- Regulatory strategies for pharma and medical devices
- QMS, ISO 13485, Annex 11, 21 CFR Part 11, ICH
- QA Agreements, MS/P Agreements, Shipment Agreements
- Audits and inspections

Objectives
- Gain the ability to ensure regulatory and quality compliance.
- Develop knowledge of global regulatory pathways.

Activities
- Case study: acquisition of a late-stage product.
- Simulation of audit preparation.

Module 3: Project Initiation & Planning
Content
- Project Charter
- Stakeholder identification and Kick-off
- WBS, Gantt, Milestones
- Budget & scheduling
- Procurement and resource planning
- Risk management

Objectives
- Develop comprehensive project initiation and planning documents.
- Perform structured project planning using PM tools.

Activities
- Creation of WBS and Gantt chart.
- Development of Risk Register and S-curve.

Module 4: Quality: Qualification & Validation
Content
- Technical specifications: URS, Change Control
- Qualification of machinery, utilities, and critical instruments (FAT/SAT; IQ/OQ/PQ)
- Computer System Validation (CSV)
- Process Validation

Objectives
- Understand qualification and validation requirements.
- Apply GMP-compliant documentation standards.

Activities
- Validation exercise on equipment and systems.

Project Execution, Monitoring, Control & Closure
Content
- KPI monitoring, dashboards, reporting
- Change management and CAPA
- Cost control and EVM
- Lessons learned and project close-out

Objectives
- Monitor and control project performance using analytical tools.
- Manage deviations, CAPA, and change requests.

Activities
- Simulation of project progress meeting.
- Exercise on deviation management.

Module 5: Team Management & Optimization
Content
- Cross-functional team leadership
- Conflict management
- Communication strategies
- Process optimization and best practices

Objectives
- Develop leadership competencies in cross-functional settings.
- Enhance communication and stakeholder engagement.

Activities
- Team dynamics case study.
- Project evaluation exercise.

Certificate of attendance.
Short Advanced Studies SUPSI in Pharmaceutical Project Management, subject to passing all exams required by the training program.

76 hour-lessons

Learning Outcomes
Knowledge and Understanding
- Describe core Project Management principles in regulated pharmaceutical environments.
- Understand roles and regulatory functions of EMA, FDA, PMDA, MHRA, and Swissmedic.
- Explain GMP, GxP, ISO 13485, Annex 11, and 21 CFR Part 11 requirements.
Applied Skills
- Develop key project initiation documents: Project Charter, Stakeholder Register, WBS, Gantt charts, and Risk Registers.
- Apply monitoring and control systems such as KPI dashboards and Earned Value Management.
- Execute validation activities (IQ/OQ/PQ, FAT/SAT) and develop URS/SoW documentation.
- Adapt Agile frameworks (Scrum, Kanban) to GxP-regulated environments.

Bloom’s Taxonomy Mapping
- Learning Outcome Bloom’s Level
- Describe core PM principles in regulated environments. Understand
- Understand regulatory authority functions. Understand
- Explain GMP, GxP, ISO 13485, Annex 11, 21 CFR Part 11. Remember / Understand
- Develop Charter, WBS, Gantt, Risk Register. Apply / Create
- Apply KPIs and Earned Value Management. Analyze / Evaluate
- Execute validation and produce URS/SoW. Apply
- Adapt Agile to GxP environments. Apply / Analyze
- Lead cross-functional teams. Apply
- Identify and mitigate risks. Analyze
- Solve project complexity challenges. Evaluate / Create

Dipartimento tecnologie innovative

March 23, 25, 30
April 14, 16, 21, 23, 28
May 5, 11, 18, 20, 27
June 1, 3, 8, 17, 22, 24, 2026

5.30 - 9.00 PM

The course will be held online

CHF 3'600.00

- Teresa Iorfida, Founder, Project Management | Leadership | D&I, Net-W Healthcare & Life Science, Roma
- Laura Castagno, Director, European Regulatory Affairs , VIVUS AG , Zug
- Roberta Frattini
- Carlo Barbera, Pipeline Project Manager, GSK, Siena

Sara Vignati, research and teacher, Department of Innovative Technologies.