The regulatory requirements concerning the control of Extractables and Leachables (E&L) have become much more onerous in recent years. This course sets out the regulatory and scientific considerations in a logical, stepwise manner and offers practical advice for compliance. The course answers questions such as: “When is an extractable/ leachable study necessary?”, “How do I choose appropriate extraction conditions?” and “How low do I need to go in terms of concentration/amount?”.
Regulators will expect a risk-based approach to compliance, and the steps involved in an E&L risk assessment are described. To facilitate a risk-based approach, typical extractables from various types of plastics will be described, and risk factors for glass erosion will be discussed. In addition, common errors in the design or application of Extractables and Leachables studies will be explained, together with insights into common analytical techniques and analytical errors.
The course includes workshops and interactive discussions.
A deeper insight into the science behind E&L evaluation
An overview of regulatory landscape and requirements for E&L studies
An appreciation of the use of E&L databases in mitigating study design and execution risks
An understanding of how to design efficient E&L studies that meet the requirements of regulatory authorities
A high-level view of recent and upcoming changes to US Pharmacopoeia (USP)
Understand how to focus on materials and products that pose the greatest risk
Improve the quality of extractable/leachable data
Answers to your questions on E&L
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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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