Course overview
Master modern stability testing so that you can design, justify, and defend robust stability programmes fully aligned with the existing ICH Q1A-Q1F + ICH Q1E + ICH Q5C + EU/CPMP & WHO Guidelines and new ICH Q1(Draft).
As products become more complex and supply chains more global, it is crucial to stay up to date with the latest regulatory expectations, statistical approaches, and best practices for stability programme design.
Stability requirements continue to tighten, with the updated ICH Q1(Draft) bringing enhanced clarity around protocol justification, statistical modelling, pooling decisions, and data interpretation. Organisations that fail to modernise their stability programmes risk delays, failed submissions, and avoidable resource costs.
This course will keep you abreast of the latest developments, providing a complete, practical, and scientifically grounded approach for small molecules and biologics alike.
CPD Hours: 18
Course Content
- Day 1
- Regulatory foundations for stability programmes
- Overview of new ICHQ1 draft
- Stability Study Types , Conditions and Protocols
- Photostability (ICH Q1B)
- Packaging Considerations
- Governance of stability samples and facilities
- Day 2
- Requirements for existing products, line extensions and variations
- Data treatment, shelf-life assignment and extrapolation
- Matrixing and bracketing stability studies
- Bulk stability
- Environmental zones considerations
- Day 3
- Stability for biopharmaceuticals
- Degradation pathways
- Analytical and bio assay considerations
- Cold chain and frozen storage stability
- Design of modern stability programme using updated ICHQ1
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.
