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Analytical Method Validation: Expert Panel Discussion on ICH Q2 Revision 2
Expert Insight & Answers | Explore how prior knowledge and development phase data can be leveraged within a validation framework, and learn what justification is required to implement this lifecycle approach effectively across your organisation.
Beyond Accuracy and Precision: Total Analytical Error and Linearity in ICH Q2 Revision 2
On-Demand Presentation by Dr. Pierre Lebrun (Cencora – PharmaLex) | Discover how an integrated validation experiment design can simultaneously address linearity, bias, and intermediate precision across the operational range, linking directly to the Analytical Target Profile and product specifications without increasing experimental burden.
Specification Setting for Biopharmaceuticals: Expert Panel Discussion on Best Practices
Expert Insight & Answers | Understand how specification setting for biopharmaceuticals requires multidisciplinary input, and learn how release and shelf life specifications are determined and differentiated based on product stability data and process capability.
From ATP to Acceptance Criteria: Mastering ICH Q2 Revision 2
On-Demand Presentation by Dr. Joachim Ermer (Ermer Quality Consulting) | Learn how to derive defensible ATP acceptance criteria directly from manufacturing and analytical performance requirements, using probability-based approaches to set specification-linked precision and accuracy limits rather than relying solely on empirical expectations.
Addressing Challenges in Analytical Validation: Understanding ICH Q2(R2) and Integration with ICH Q14
On-Demand Presentation | Gain practical guidance on adapting validation practices for biotechnological analytical methods, including cell-based assays and platform technologies, and explore strategies for addressing common gaps in regulatory filing packages.
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