Course overveiw
Modern regulators increasingly expect manufacturers to demonstrate that processes remain in a continuous state of control throughout the full product lifecycle - not only during initial validation. Authorities such as the United States Food and Drug Administration, the European Medicines Agency, the Medicines and Healthcare products Regulatory Agency, and the World Health Organization now place strong emphasis on effective monitoring, trending, and proactive management of manufacturing processes.
This two-day training course is designed for life science professionals who need to apply Statistical Process Control confidently, even if they do not have a statistics background. All concepts are taught from first principles using clear explanations, visual interpretation, and step-by-step manufacturing examples.
The course links Statistical Process Control to continued and ongoing process verification expectations and aligns learning with international guidance and standards including:
- The United States Food and Drug Administration Process Validation Guidance (Stage 3: Continued Process Verification)
- European Union Good Manufacturing Practice Annex 15 requirements for ongoing monitoring and trend review
- International Council for Harmonisation guideline on Pharmaceutical Quality Systems (Product Quality Monitoring System expectations)
- World Health Organization expectations for quality monitoring and performance control
- International standard for medical device manufacturing quality management systems, including process monitoring and critical-to-quality trending
Delegates will learn how to create and interpret control charts, detect meaningful process shifts, distinguish normal variation from abnormal variation, and build a structured governance system that supports inspection readiness and continual improvement.
Every session includes interactive learning activities designed around inspection-style scenarios. This ensures delegates understand not only the tools, but also how to build evidence that can confidently answer inspector questions such as:
- How do you know your process remains in control?
- Where is your trend review evidence?
- What triggers an investigation and how is this documented?
By the end of the course, delegates will be equipped to apply Statistical Process Control as both a compliance tool and a continuous improvement tool, supporting stronger product quality assurance and improved operational performance.
CPD Hours: 12
Course Content
- Day 1
- Regulatory foundations for SPC
- SPC fundamentals in manufacturing processes
- Process capability and practical statistical interpretation
- Governance of continued process verification and data review
- Day 2
- Implementing SPC in Production
- Modern monitoring tools for process control
- Current challenges and industry trends
- Workshop: applying SPC to real cases
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.
