Approved training courses

Course description

Stability failures are responsible for a third of product recalls, costing pharmaceutical companies millions. The risk of not conducting thorough stability testing therefore outweighs the cost of performing it. This interactive 2-day course will provide you with an understanding of the science behind stability testing, a detailed examination of the ICH guidelines and accurate assessments of the tools and techniques to carry out testing. The course will also highlight the fundamentals you need to consider and can transfer back to your work place.

This course will allow you to:
- Understand the chemistry principles behind stability studies
- Design a stability program compliant to ICH/FDA guidelines
- Analyse stability data and derive your product shelf life
- Improve efficiency through matrixing and bracketing
- Comply with current GMP requirements to avoid inspection failure
- Interpret Q1A, Q1B and Q1E
- Prepare for FDA inspection of your stability labs
- Understand the Barr decision and thoroughly investigate OOS stability results

This course is led by Dr Geoff Carr. Geoff was appointed as Manager, Analytical Development at Patheon Inc, Ontario, Canada in 2000 and is now Director, Analytical Development. Prior to that, he held positions of Manager, Analytical Sciences at Celltech-Chiroscience, UK, Head of Analytical Development at Medgenix, Belgium and before that at Wyeth Research, UK.
He originally started his career in pharmaceutical analysis at The British Pharmacopoeia Laboratory where he was finally appointed Head of the Laboratory. He has been a Member of various British Pharmacopoeia Committees and a UK representative to Committees of the European Pharmacopoeia and is now a Member of the General Chapters – Chemical Analysis Expert Committee of USP. He is the author of several journal publications, book chapters and has presented at numerous international conferences on various topics related to pharmaceutical analysis.


On request from training provider

Additional info

Lunch and refreshments are provided.

Teaching method





2 days


On request from training provider

Training provider

Pharmaceutical Training International



+44 (0) 20 7017 7481

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