The 3rd edition of the Analytical Method Validation & Lifecycle Excellence Masterclass is a comprehensive two-day virtual program designed to equip analytical scientists, quality professionals, and regulatory specialists with the knowledge and tools needed to navigate the evolving landscape of analytical method validation. Recent regulatory developments, including ICH Q14 and the revised ICH Q2(R2), have fundamentally shifted the approach to analytical method development and validation. This course bridges the gap between traditional validation practices and modern Quality by Design (QbD) principles, ensuring your methods not only meet current regulatory expectations but are designed for long-term success. Through a combination of theoretical frameworks, regulatory insights, and hands-on workshops, participants will develop practical skills in method development, validation, verification, and transfer. The program emphasizes real-world application, helping you avoid common pitfalls and implement robust analytical control strategies that support product quality throughout the entire lifecycle. Whether you're developing methods for biological or chemical drugs, this masterclass provides the comprehensive understanding needed to create robust, regulatory-compliant analytical procedures that stand the test of time.
Navigate EU and US compendial guidance for HPLC and GC methods with confidence
Learn systematic approaches to method development that reduce validation failures and post-approval changes
Develop methods with superior performance characteristics through improved documentation and control strategies
Understand FDA and compendial expectations to ensure smooth regulatory submissions and inspections
Master proven strategies for seamless method transfers between sites and organizations
Learn when to use validation, verification, or transfer approaches for maximum efficiency
Create comprehensive yet efficient documentation that meets regulatory requirements
Master the latest ICH Q14 and Q2(R2) guidelines and understand their practical implications for your work
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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.
