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Learn the role of extractables and leachables (E&L) in drug quality, their sources, and their impact on pharmaceutical impurities, with a focus on ICH Q3E and the new draft guidance.
Get practical guidance on designing E&L studies, including risk-based approaches, extraction conditions, and meeting ICH Q3E and USP requirements.
Use QRM tools to assess risk and evaluate materials for drug product compatibility, following ICH Q3E principles.
Understand key techniques for detection, quantification, and identification of E&L — and how to avoid errors in execution and interpretation.
Three half-days of expert-led Zoom sessions packed with case discussions, Q&As, and real-world scenarios
All slides, tools, and supporting materials available in one place - before, during, and after the course.
Receive a digital certificate (also LinkedIn-ready) that verifies your skills in strategic trial planning.
Gain a solid foundation in how E&L impact product quality and fit into the broader impurity control framework.
Learn how to interpret and apply global guidance from ICH Q3E, USP /, and Ph. Eur., using QRM tools to support compliance.
Master the steps to plan, execute, and assess E&L studies—including selecting extraction conditions, applying AETs, and interpreting results.
Identify potential leachables from various container types, assess corrosion and additive risks, and select suitable packaging materials.
Understand the strengths and limitations of key analytical techniques, and avoid common errors that compromise E&L data quality.
Designed for professionals who want to enhance their expertise and advance their careers
Mark Powell Scientific Limited, UK, Director
Dr Mark Powell 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 several 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 pharmaceutical development, chromatography, spectroscopy, dissolution testing, data integrity, control of impurities, technical writing, and stability/stress studies.
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“I really appreciated the practical examples and the workshops at the end of each seminar day. They helped reinforce the concepts and made it much easier to understand the topic in practice. Thank you, Dr. Mark Powell, for a very well-organized and highly informative online seminar.”Andreas Doukas
“The course was very well structured and included helpful case studies that made the topics easier to understand. It exceeded my expectations and I’m taking away a lot of new knowledge.”Marion Broneske
“The training provided a very useful overview of the key regulatory guidance. I also highly appreciated how quickly and clearly Mark answered participants’ questions.”Mark Kuil