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.
CPD Hours: 12
Course Content
- Day 1
- Introduction to pharma projects and industry standards
- Project lifecycle and quality by design
- Risk and change management
- Procurement and construction management
- Day 2
- Commissioning and qualification (C&Q) strategies
- Facility delivery by modality: sterile/biologics/ATMP/potent OSD
- Regulatory and quality compliance
- Innovation and acceleration in projects
- Project close-out and post-project
- Case Study
Speakers
Paul Palmer
Paul R Palmer is a Director / Pharmaceutical Consultant and a practicing EU / UK Qualified Person. He has over 35 years experience in the pharmaceutical industry in the development, manufacture and supply of medicinal products and medical devices.
Throughout his career, Paul has intentionally taken on all opportunities as they arose in order to develop a broad range of knowledge with an in-depth detailed understanding of manufacturing, storage, distribution, research, computerised systems, as well as the facilities and services to support each.
People and systems have always been a core focus, how to ensure best use, optimise and enhance efficiency. He has a level of curiosity rarely displayed in people taking on the qualified person role in pharmaceutical manufacturing. Culture, behaviour and psychology are all significant influences on the systems and processes we implement, but are often ignored.
Paul studied psychology as part of his MSc in 1993 and has always enjoyed observing the world around him with a curiosity that is rarely satisfied.
