CAS Pharmaceutical Project Management & Regulatory Compliance

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CAS Pharmaceutical Project Management & Regulatory Compliance

This course provides a comprehensive and structured overview of Project Management methodologies applied to the pharmaceutical and medical device sectors. It integrates regulatory frameworks, quality systems, validation processes, and Agile methods adapted to GxP environments. Through lectures, case analyses, practical exercises, and applied project work, learners gain skills in initiating, planning, executing, monitoring, and closing projects within regulated contexts

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SUPSI Course Overview

Overview

  • Degree awarded

    CAS Pharmaceutical Project Management & Regulatory Compliance

  • Credits

    10.0 ECTS

  • Start date

    March 23rd, 2026

  • Finish date

    October 27th, 2026

  • Registration deadline

    March 6th, 2026

  • Language

    English

  • Fee

    CHF 5600 *

  • Duration

    124 Tuition hours

  • Performance method

    Online learning

  • Attendance

    Evening

*Detailed information available under Additional Cost Details

Course Text Info

- Provide a strong foundational understanding of Project Management in regulated pharmaceutical environments.
- Develop the ability to initiate, plan, execute, monitor, and close projects aligned with compliance and quality requirements.
- Strengthen learners’ capability to integrate regulatory frameworks into project planning and execution.
- Enhance team management, communication, and leadership skills in cross-functional project settings.
- Enable practical application of Agile and traditional PM methodologies within GxP constraints.
- Cultivate problem-solving and decision-making abilities in complex regulated project scenarios.

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- 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.

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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.

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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.

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Advanced Studies

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Module 1 - Fundamentals of Project Management in the Pharmaceutical Sector
Module 2 - Regulatory Affairs, Quality & Compliance
Module 3 - Project Initiation & Planning
Module 4 - Quality: Qualification & Validation/Project Execution, Monitoring, Control & Closure
Module 5 - Team Management & Optimization
Module 6 - Agile Project Management in Pharma

Course Text Info

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

Course FC Study Program

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SUPSI Course FC Dates

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

Module 6
- September 15, 17, 22, 24, 29
- October 1, 6, 8, 13, 15, 20, 27, 2026

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5.30 - 9.00 PM

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SUPSI Course FC Locations

The course will be held online.

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Dipartimento tecnologie innovative

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CHF 5,600.00

SUPSI Alumni members benefit from a 15% reduction on the registration fee. The reduction is valid if the person can prove that they have already paid the SUPSI Alumni membership fee at the time of registration. The 15% reduction on the registration fee cannot be combined with other discounts.

Course Text Info

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

SUPSI Course FC Contacts

SUPSI Course FC Responsibles

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

SUPSI Course FC Teachers

- 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, Senior consultant, FRABI Consulting SA
- Carlo Barbera, Pipeline Project Manager, GSK, Siena

Course Contact

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