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Stability Studies throughout the Product Life Cycle

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Join Dr. Mark Powell as he looks at the various stability studies conducted from the start of pharmaceutical development to the manufacture of marketed product. Dr. Mark Powell also explains the purpose of each study and highlights some of the potential pitfalls.

Topics covered include:

  • Aims of stability evaluation
  • The effect of environmental factors and the primary pack
  • API stability
  • Excipient compatibility
  • Prototype stability (including accelerated stability using the ASAP model and stress stability studies)
  • Bulk hold studies
  • In-use stability
  • Registration stability
  • Shipping excursion studies

Guest speaker

Dr. Mark Powell, Director at MP Scientific

Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016. He has worked at a senior level in a number of companies with responsibility for analytical development and equipment qualification.

In 2010 Mark was appointed Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for guiding the direction of drug development programmes as well as establishing collaborations with academia and instrument manufacturers. In 2013, he set up his own company to provide training and consultancy services to the pharmaceutical industry. His consultancy work has involved, amongst other things, managing the analytical aspects of pharmaceutical development programmes and conducting data integrity audits.

He is in demand as a trainer in topics such as chromatography, spectroscopy, dissolution testing, data integrity, control of impurities, technical writing, stability/stress studies, method validation, extractables and leachables, and root cause analysis.