Stability evaluation occurs at various stages during the development of a drug product. At early development stages, it is used to select formulations and packaging configurations that are most likely to give a commercially viable shelf life. At later stages, stability data from formal studies is used to justify product shelf life (in the primary pack), shipping excursions and process hold times. This course covers the science behind stability evaluation as well as regulatory expectations.
Stability Testing of Pharmaceuticals Masterclass is a live, two-days course, which begins with an overview of the types of stability study conducted, followed by a review of common chemical degradation reactions. It is important that forced degradation studies are predictive of real-time and accelerated conditions, and an approach that makes this more likely is described, including the use of a humidity-corrected Arrhenius model(Accelerated Stability Assessment Programme, or ASAP).
Within the ICH regions (Climatic Zones I and II), the Q1 stability guidelines are followed, but for companies seek-ing global approval for new drug products, the requirements for other regions are described. The science behind photo stability evaluation is explained, together with the requirements for data trending and reduced study designs (bracketing and matrixing). The stability of biological products (ICH Q5C) is described, together with typical protein degradation pathways and analytical approaches. Stability chamber management is an important element of a successful study, and acceptable approaches to excursions are explained.
The quality of test methods used for stability evaluation is also an important consideration, and the course includes a brief introduction to analytical QbD and lifecycle management, and well as data trending and the identification of out-of-trend results. Degradation product growth is often the factor that limits the shelf life of anew drug product, and approaches for justifying impurity levels are explained, including requirements for genotoxic impurities. Finally, since regulators continue to focus on data integrity during regulatory inspections, acceptable approaches to data management, including chromatographic integration, are explained, together with recent examples of regulatory enforcement action relating to stability studies.
An overview of regulatory requirements for stability studies.
A deeper insight into the science behind stability evaluation.
An appreciation of the use of stability evaluation at each stage of drug development.
An understanding of how to design efficient stability studies that meet the requirements of regulatory authorities.
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Dr. Mark Powell brings over thirty years of senior analytical chemistry experience to this comprehensive masterclass. As a Fellow of the Royal Society of Chemistry (RSC), he has served in leadership roles including Honorary Secretary and Honorary Treasurer of the RSC's Analytical Division, where he led initiatives in continuing professional development.
His extensive industry experience spans senior analytical roles across multiple pharmaceutical companies, with direct responsibility for analytical development, method validation, and equipment qualification. In 2013, Dr. Powell founded his own consultancy to provide specialized training and consulting services to the pharmaceutical industry.
Dr. Powell's consulting work encompasses managing analytical aspects of pharmaceutical development programs during both early and late-stage development, as well as troubleshooting complex analytical problems. His training programs are highly sought after for their practical approach and real-world applicability.
Training Philosophy: Dr. Powell's teaching approach emphasizes practical application of regulatory concepts, helping participants not just understand the requirements but successfully implement them in their daily work. His extensive troubleshooting experience provides valuable insights into common challenges and proven solutions.
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