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Trending Stability Data

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Pharmaceutical regulators have made it clear that the same investigation approach should be adopted for out-of-trend (OOT) results as for out-of-specification (OOS) results. However, regulators offer little guidance on identifying OOT data.  For OOT results to be identified promptly during stability studies, data must be continuously trended in some way.  The problem is that trends are often not obvious during the early phases of a stability study.  This webinar offers some practical approaches for the continuous trending of stability data and covers:

  • Regulatory expectations for OOT results
  • When is a result OOT?
  • Identifying OOT results
    • Regression control chart
    • By-time-point method
    • Slope control chart method

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.