This session will provide a comprehensive overview of the ICH Q3D guidelines, which are designed to ensure patient safety by limiting exposure to potentially harmful elemental impurities in pharmaceutical products. Experts will then discuss what the guidelines mean to key teams, from regulatory affairs to quality teams, across the entire product lifecycle and how the automated principles within our latest software tool, Vitic Q3D, support you to build a robust control strategy.
Join Christopher Day (Director of New Modalities Analytical, AstraZeneca), Dr. Roberta Drekener (Senior Application Scientist, Lhasa Limited) and Amber Carr (Business Partnerships Executive, Lhasa Limited) for an engaging webinar that delves into the intricate world of ICH Q3D assessments for elemental impurities.
Learn about the history and impact of the Lhasa Limited Elemental Impurities Data Sharing Initiative, a collaborative effort that has brought together industry experts to curate a robust database supporting more scientifically driven risk assessments under ICH Q3D. Gain insights into how this initiative has streamlined the assessment process, reducing unnecessary testing and enhancing confidence in excipient risk evaluations.
In addition, industry expert Christopher Day will present a compelling case study showcasing how they utilised this curated database to conduct their Q3D assessments efficiently and effectively.
Don’t miss this opportunity to deepen your understanding of automated ICH Q3D risk assessments for your drug product formulations. See how you can build a robust control strategy based on shared analytical data, significantly shortening assessment timelines and reducing the need for analytical testing.
What you’ll learn:
- Understanding the ICH Q3D guidelines: Gain a clear understanding of the ICH Q3D guidelines, including their purpose, scope, and practical applications in managing elemental impurities in pharmaceutical products and defining your control strategy.
- Explore the Lhasa Limited Elemental Impurities Data Sharing Initiative:Learn about the history and development of this collaborative industry effort, and discover how this curated database has been designed to support scientifically robust Q3D assessments.
- Learn practical applications of the database:Presentation of a real-world case study will demonstrate how Lhasa’s curated database was utilised to streamline and enhance AstraZeneca’s Q3D assessments.
- Enhance risk assessment strategies with Vitic Q3D:Discover how shared data and collaborative tools translate into a more robust control strategy. Learn how this optimises your end-to-end product lifecycle management, reducing unnecessary testing, improves confidence in your excipient risk evaluations and optimises your approach to elemental impurity risk assessments.
Register now to secure your place and gain valuable insights into optimising your Q3D assessments!