Course overview
Ensure your manufacturing processes are validated from end to end using modern, science-based practices that meet today’s global regulatory standards. In an era where regulators treat validation as a lifecycle activity rather than a one-time exercise, this course provides comprehensive training on how to design, qualify, and maintain processes in a state of control.
Over two days, participants will learn to integrate process validation and equipment/facility qualification into a unified strategy, aligned with FDA’s 2011 Process Validation Guidance, EU GMP Annex 15, UK MHRA expectations, and WHO guidelines. The programme walks through each stage - from initial process design and scale-up (Stage 1), through Installation/Operational/Performance Qualification (IQ/OQ/PQ) and Process Performance Qualification (PPQ) (Stage 2), into ongoing Continued Process Verification (CPV) programs (Stage 3).
Emphasis is placed on a risk- and science-based approach: leveraging tools like Quality by Design (QbD), Design of Experiments (DOE), and Process Analytical Technology (PAT) to build quality into the process, and using data analytics to monitor performance. Participants will also learn how to handle re-validation when changes or transfers occur, and how to document validation activities to satisfy inspectors. This course ensures you can validate processes efficiently and right-first time, supporting both compliance and operational excellence.
CPD Hours: 12
Course Content
- Day 1
- Validation fundamentals and execution
- Module 1: Regulatory overview of validation
- Module 2: Stage 1 - Process design & risk assessment (practical application)
- Module 3: Stage 2.1 - qualification (IQ/OQ)
- Exercise 1: Building an equipment qualification strategy
- Module 4: Stage 2.2 - PPQ / PQ execution
- Module 5: Stage 3 - OPV / ongoing process verification
- Exercise 2: SWOT analysis of validation strategy
- Day 2
- Advanced Topics and Maintaining Control
- Module 6: Validation documentation & data integrity (ALCOA+)
- Exercise 3: Designing an OPV system
- Module 7: Advanced validation techniques
- Module 8: Maintaining the validated state & change control
- Module 9: Workshop - Validation Plan Build
- Exercise 4 : Change scenario: assess revalidation requirements
- Module 10: Inspection readiness & lessons learned
- Case Study: Building a sustainable ongoing verification programme
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.
