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Stability Testing for Pharmaceuticals

21 - 22 November 2017

Radisson Blu Edwardian Grafton, London

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, 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.

  • 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

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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