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
Farah Nadeem
Farah Nadeem is an Operations Manager at Paul R. Palmer Limited/ Pharmaceutical Consultant and a Trainee Qualified Person. Farah is a Pharmacist and recognised QA expert and has over 20 years of experience in the Pharmaceutical industry in the development, manufacture and supply of medicinal products.
Throughout her career, she has held various quality assurance roles and actively pursued new opportunities to expand her knowledge and expertise. As a result, she has gained a comprehensive understanding of manufacturing, storage, and distribution processes, as well as the facilities and services that support them. Involved in documentation management: writes, reviews, and audits SOPs and QMS implementations. Assists companies in meeting regulatory requirements.
In her current role as a QA Operations Manager for a Pharmaceutical Consultant Company, Farah Nadeem provides various solutions, including assistance in obtaining the first MIA(IMP) and MIA licenses, as well as preparation and hosting for regulatory inspections. Her work involves collaborating with Paul Palmer to offer services such as QP declarations for API manufacturers, regulatory inspection hosting, commercial and clinical batch release, compliance audits, and coaching and training in GxP.
Aneta Jell
Aneta Jell is a seasoned Quality Assurance professional with over 20 years of experience
across manufacturing, contract operations, and quality leadership in the pharmaceutical
industry. Currently serving as Quality and training manager at PaulPalmer limited she
oversees global contract manufacturing quality, ensuring GxP compliance, regulatory
alignment, and supply chain integrity. Her expertise spans GMP, ISO 9001, ISO 17025, and
QMS administration, with proven strength in audits, CAPA, deviations, and technical
agreements. A qualified QMS lead auditor with bilingual proficiency in English and Slovak,
Aneta is recognised for driving continuous improvement, fostering compliance culture, and
leading high-performing quality and HSE teams.
Who Should Attend
Who should attend?
- Development scientists
- Analytical chemists
- Stability programme leaders
- QC/QA specialists
- Regulatory affairs professionals
- CMC and technical development teams
- Formulation scientists
