Chemical Drug Specifications 2.0 Masterclass is a comprehensive two-day virtual masterclass designed to equip analytical scientists, formulation scientists, and regulatory professionals with the knowledge and skills needed to develop robust, scientifically justified specifications for drug substances and drug products.
In the evolving regulatory landscape emphasizing Quality by Design (QbD), specifications play a crucial role in the overall control strategy. This course bridges traditional specification-setting approaches with modern QbD principles, ensuring your specifications not only meet current regulatory expectations but effectively manage patient risk throughout the product lifecycle.
Through a combination of regulatory guidance review, scientific principles, and hands-on workshops, participants will develop practical skills in risk assessment, specification setting, and justification strategies. The program emphasizes real-world application, helping you navigate complex regulatory requirements while maintaining scientific rigor in your approach to quality control.
Whether you're working with immediate release tablets, complex parenteral formulations, or novel drug delivery systems, this masterclass provides the comprehensive understanding needed to create specifications that protect patients while enabling successful product development and registration.
Master Current Regulatory Expectations - Understand ICH, EMA, and FDA guidance on drug substance and drug product specifications
Implement Quality by Design Principles - Learn systematic approaches to specification setting that reduce regulatory risk
Control Emerging Impurity Risks - Master nitrosamine control strategies and genotoxic impurity management
Develop Risk-Based Control Strategies - Use quality risk management to justify specifications and testing strategies
Navigate Complex Dosage Form Requirements - Understand specification requirements for various routes of administration
Justify Specifications Above ICH Limits - Learn systematic approaches to support higher impurity levels when appropriate
Optimize In-Process vs. Finished Product Testing - Balance control strategy elements for maximum efficiency
Set Discriminating Dissolution Tests - Master dissolution specification setting for different drug classes
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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.
