As early as 2018, the ICH announced that the Q2(R2)/Q14 Expert Working Group (EWG) would develop a new ICH quality guideline, ICH Q14, for the development of analytical methods and revise the ICH Q2(R1) guideline for the validation of analytical procedures. This will complement the existing ICH Q8 to Q12 guidance and the current ICH Q13 guidance for continuous manufacturing. The new Analytical Procedure Development Guideline (Q14) will then be relevant for sections S4, P4 and P5 of the CTD and should be seen together with Q8(R2) and Q11 as a supplement to the guidelines. The use of the enhanced approach to analytical procedures development and validation can contribute to resource-efficient drug development as well as submission process or facilitate changes after CMC approval. The revised Q2(R1) guideline will also be relevant for sections S4, P4 and P5 of the CTD, with an emphasis on systematic analytical development. As development and validation are linked and subsequent steps, both guidelines will be worked on by the same Expert Working Group, with a potential to combine both documents into one.
We're glad to be running the 2nd edition of the Analytical Method Validation & Lifecycle Management Masterclass, which aims to explain these new guidance in the context of other compendial and regulatory agency expectations and to help attendees avoid common mistakes during the development, validation, verification, transfer and post-approval change of test methods, whether for biological or chemical drugs. Key concepts such as the Analytical Target Profile (ATP) and Analytical Control Strategy (ACS) will be explained with examples. Test methods often lack robustness because of poor documentation, which can lead to errors or high variability during routine use or method transfer. A risk-based approach to method documentation is included in the course.
Each day will conclude with a workshop that will give participants the opportunity to put into practice what they have learned.
Key Topics
Learn how to write an effective ATP
Learn how to set meaningful system suitability criteria as part of the overall ACS
Dive deep into writing method validation, verification and transfer protocols and setting appropriate acceptance criteria
Understand allowable changes to compendial chromatographic methods
Understand how you can avoid common errors in test method documentation and follow a risk-based approach
Learn how to deal with method validation failure
Design suitable method validation, verification and transfer experiments
Get yourself updated on current regulatory expectations including EMA guidance
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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.
