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Platform Analytical Procedures, beyond the technical challenges
On-Demand Presentation | Learn from GSK experts to identify significant challenges and practical solutions for deploying and maintaining platform analytical procedures throughout different development and lifecycle stages.
Opportunities and challenges from ICH Q2 (2) and Q14 for the analytical lifecycle
On-Demand Presentation | With experts from GSK | Assess the practical implications of established conditions for lifecycle flexibility and regulatory engagement, and gain a forward-looking perspective on how widespread adoption of these guidelines will shape the future of analytical lifecycle management.
Regulatory expectations for your HCP analysis: meet USP <1132.1> to enhance the quality of MS-based data
On-Demand Presentation | Incl. panellist from U.S. Pharmacopeia (USP) | Compare the pros and cons of the three HCP quantification methods outlined in USP 1132.1, and gain insight into how LC-MS/MS enables more specific identification and quantification of individual HCPs beyond what traditional ELISA approaches can provide.
A Practical Approach to Implementing ICH Q14: Tools for Analytical Quality by Design in Capillary Electrophoresis Method Development
Meet the Expert: Dr. Ewoud van Tricht | Discover how capillary electrophoresis, developed using Design of Experiments, can replace slower techniques like qPCR for adenovirus quantification, cutting analysis time from days to under an hour.
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.
Analytical Quality by Design: from Quality Target Product Profile to the Analytical Target Profile
On-Demand Presentation by Prof. Sandra Furlanetto (University of Florence) | Learn how the Analytical Target Profile functions as a forward-looking framework for defining performance criteria under ICH Q14, and understand how AQbD shifts method development from trial-and-error to a rational, knowledge-driven process applicable to both small molecules and biopharmaceuticals.
Analytical Quality by Design: Critical Analytical Procedure Parameters and Risk Assessments
On-Demand Presentation by Dr. Cyrille Chéry (UCB) | Discover how prior knowledge can be formally integrated into the risk assessment process to reduce redundant effort across projects, and explore how risk scoring and mitigation planning guide development decisions, including when targeted experiments are needed to validate a parameter's assigned risk level.
Analytical Quality by Design: Analytical Procedure Control Strategy (ACPS)
On-Demand Presentation by Dr. Lars Geurink (Batavia Biosciences) | Understand what the Analytical Procedure Control Strategy is under ICH Q14, how it connects every stage of method development into a coherent control framework…Understand what the Analytical Procedure Control Strategy is under ICH Q14, how it connects every stage of method development into a coherent control framework, and why "fit for purpose" is the correct standard for evaluating analytical procedures.
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