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Stability Testing for Pharmaceuticals

2020 Dates TBC

Radisson Blu Edwardian Grafton, London

Stability testing is a major requirement in the development of a pharmaceutical product to determine the versatility of a drug substance when exposed to certain conditions such as heat, pH, humidity and radiation. It is vital for patient safety to know how a drug product will change over time and to provide adequate advice for storage and disposal of the product. 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. Crucially you will gain a deeper understanding of the guidelines and how best to create stability protocols to maintain compliance. . 

  • 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

Dr Geoff Carr

Geoff Carr 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 held several posts and 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.

This course is highly recommended for anyone working in pharmaceuticals, in the following departments, fields or positions:

  • Stability
  • Analytical Chemistry/Methods
  • Formulation Development
  • QA/QC
  • Manufacturing/Production
  • Method Validation
  • Regulatory Affairs
  • GMP Compliance
  • Chemical Engineering
  • Development/Chemistry
  • Outsourcing
  • R&D Analyst / Assistant
  • Stability Officer / Supervisor / Analyst/ Coordinator
  • Analytical Development Engineer
rsc logo approved training

This course is approved by the Royal Society of Chemistry for the purpose of continuing professional development.

As the UK’s professional body for chemical scientists, the Royal Society of Chemistry supports professional development by listing excellent training opportunities on their database of approved courses. The approval process is one of peer review, involving assessment against set criteria by members that are expert in their field.

The content of the course was excellent and I learned a lot about regulations that I didn't know. It also included more interaction than other courses I have attended which was great.

R&D Scientist Stability Department, Convatec

I enjoyed that it was a small group and therefore there were good informal discussions. I attended as a refresher on stability but I've learned a lot.

Stability Team Manager, Custom Pharma Services

Specifications for Small Molecule Drug Products Webinar

Led by Dr Mark Powell, a Fellow of the Royal Society of Chemistry (RSC) with over 25 years’ experience as a senior analytical chemist. In 2013, Mark set up Mark Powell Scientific, a company that offers training and consultancy services in analytical chemistry.

The webinar will cover: 
• Regulatory guidance (ICH, FDA, EMA) 
• Tests appropriate to different dosage forms 
• Dissolution specifications for immediate-release, modified-release and extended-release drug products 
• Dissolution specifications in the context of the biopharmaceutical classification system 
• Control of polymorphism, enantiomeric purity, drug-related impurities and microbiological contamination 
• Specifications for combination drug products 
• The role of specifications in maximizing drug product stability

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