Pharma Facility Project Management: Delivering GMP (Good Manufacturing Practice)‑Compliant Sites On Time and Within Budget Training Course

Course overview

As the pharmaceutical facility projects become increasingly complex, regulated, and time-sensitive, organisations are under intense pressure to design and commission new manufacturing facilities that are GMP-compliant from the beginning. Demand for additional production capacity, spanning sterile plants, biologics production, and advanced therapy (ATMP) is at its peak, so any missed step, a schedule overrun, budget escalation, or compliance gap, can result in serious operational and financial risks.

This intensive two-day course offers delegates training on planning and executing pharmaceutical facility projects under strict GMP requirements. The programme follows the entire project lifecycle, where participants will learn how to develop realistic project scopes, build integrated project schedules, and embed regulatory compliance and Quality by Design (QbD) principles into every phase of the project.

This course also  examines  industry best practices in scope management, cost control, risk management (aligned with ICH Q9 guidelines), and change control. Case studies and interactive exercises allow delegates to apply these concepts and meet new regulatory guidelines (from FDA, EMA, MHRA, PIC/S, and WHO).

By blending both the technical and managerial aspects of project delivery, this course equips delegates with the skills to lead cross-functional teams (engineering, QA/QC, validation, operations) and deliver facilities right-first-time on time, while ensuring they are inspection-ready for regulatory approval.

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines.

Benefits of attending

• Learn to integrate Compliance into Projects
• Apply a structured lifecycle approach (from concept to C&Q and close-out
• Implement risk management and change control practices (aligned with ICH Q9 and PMI frameworks)
• Understand how to plan and oversee commissioning and qualification activities (IQ/OQ/PQ) as part of the project
• Develop strategies to coordinate engineers, contractors, QA/QC, validation, and operations teams, clarifying roles and communication to keep complex projects on track
• Adapt to Emerging Challenges
• Master techniques to keep projects within schedule and budget
• Ensure the facility and documentation will pass pre-approval inspections (e.g. FDA/MHRA site inspections) on the first

Who should attend

• Project managers and project engineers
• Engineering and Facility managers
• Validation professionals
• Quality assurance and compliance specialists
• Manufacturing and operations managers 
• Consultants, EPCM contractors, and engineering service providers

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