ICH Q2(R2) Archives - BioQC

ICH Q2(R2)

Advertisement

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

by BioQC Webinar

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.

Beyond Accuracy and Precision: Total Analytical Error and Linearity in ICH Q2 Revision 2

by BioQC Webinar

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.

From ATP to Acceptance Criteria: Mastering ICH Q2 Revision 2

by BioQC Webinar

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

by BioQC Expert Forum

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 Method Validation: Expert Panel Discussion on ICH Q2 Revision 2 Practical Implementation

by BioQC Summary

Expert Insight & Answers | Gain clarity on the distinction between instrument response linearity and whole-procedure linearity, and explore how adopting response function terminology can improve consistency and reduce confusion across different calibration model types.

Analytical Method Validation: Expert Panel Discussion on ICH Q2 Revision 2

by BioQC Summary

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.

Webinar

Opportunities and challenges from ICH Q2 (2) and Q14 for the analytical lifecycle

BioQC 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.

Webinar

Platform Analytical Procedures, beyond the technical challenges

BioQC 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.

Summary

Analytical Method Validation: Expert Panel Discussion on ICH Q2 Revision 2 Practical Implementation

BioQC Expert Insight & Answers | Gain clarity on the distinction between instrument response linearity and whole-procedure linearity, and explore how adopting response function terminology can improve consistency and reduce confusion across different calibration model types.

Summary

Analytical Method Validation: Expert Panel Discussion on ICH Q2 Revision 2

BioQC 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.

Webinar

Beyond Accuracy and Precision: Total Analytical Error and Linearity in ICH Q2 Revision 2

BioQC 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.

Webinar

From ATP to Acceptance Criteria: Mastering ICH Q2 Revision 2

BioQC 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.

Expert Forum

Addressing Challenges in Analytical Validation: Understanding ICH Q2(R2) and Integration with ICH Q14

BioQC 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.

Advertisement