Analytical Development & Quality Control (QC) Archives - Page 3 of 6 - 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.

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.

Analytical Target Profiles and Method Development in ICH Q14: A Panel Discussion on Best Practices

Expert Insight & Answers | Learn how and when ATPs can be appropriately revised during method development, and explore the bidirectional review process needed to ensure any changes remain scientifically justified and aligned with the overall control strategy.

ICH Q14 Implementation: Expert Panel Discussion on Analytical Method Development

Expert Insight & Answers | Explore how multivariate optimisation tools such as risk assessment, Design of Experiments, and MODR studies can be applied modularly to strengthen method development and inform validation, without replacing fundamental analytical understanding.

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.

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.

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.

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.

Statistically Sound Specification Setting – A Practical Approach Consistent with ICH Q6B and Q14

BioQC On-Demand Presentation by Dr Eric Rozet (GSK) | Discover how Design of Experiments, statistical process control, and stability modelling contribute to a comprehensive, statistically grounded specification-setting framework aligned with ICH Q6B and Q14, and explore how Bayesian methods can incorporate prior process knowledge to strengthen this approach.

Analytical Target Profiles and Method Development in ICH Q14: A Panel Discussion on Best Practices

BioQC Expert Insight & Answers | Learn how and when ATPs can be appropriately revised during method development, and explore the bidirectional review process needed to ensure any changes remain scientifically justified and aligned with the overall control strategy.

ICH Q14 Implementation: Expert Panel Discussion on Analytical Method Development

BioQC Expert Insight & Answers | Explore how multivariate optimisation tools such as risk assessment, Design of Experiments, and MODR studies can be applied modularly to strengthen method development and inform validation, without replacing fundamental analytical understanding.

Analytical Quality by Design: from Quality Target Product Profile to the Analytical Target Profile

BioQC 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.