Guidelines & Compliance Archives - Page 2 of 4 - BioQC

Guidelines & Compliance

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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)

by BioQC Webinar

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.

ICH Q14 Analytical Procedure Development

by BioQC Webinar

On-Demand Presentation by Dr. Christof Finkler (F. Hoffmann-La Roche AG) | Understand the objectives and development history of ICH Q14, and learn how the minimal and enhanced approaches form a spectrum of increasing procedural understanding, lifecycle flexibility, and more suitably justified established conditions.

ICH Q14: Guideline Overview for Analytical Procedure Lifecycle Management

by BioQC Article

Read Article | Full text | Obtain a clear overview of the ICH Q14 guideline and understand how its lifecycle management framework integrates method development, validation, and continual improvement into a cohesive, science-based approach.

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

by BioQC Summary

Panel Q&A | PDF download | 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

Panel Q&A | PDF download | 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.

ICH Q14 Implementation: Expert Panel Discussion on Analytical Method Development

by BioQC Summary

Panel Q&A | PDF download | 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 Target Profiles and Method Development in ICH Q14: A Panel Discussion on Best Practices

by BioQC Summary

Panel Q&A | PDF download | 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.

Overcoming key challenges in understanding and implementing guideline ICH Q14 for Analytical Procedure Development

by BioQC Expert Forum

On-demand Presentation | Gain a comprehensive overview of ICH Q14 and understand the shifting regulatory landscape around analytical procedure development, including the balance between enhanced risk-based approaches and existing industry practices.

Learning Hub

ICH Q14 Guidelines: Fundamentals of Analytical Procedure Development

BioQC Stay ahead on guidelines | Curated Educational Resources | Learn the difference between minimal and enhanced approaches to analytical procedure development, and how implementing more elements of the enhanced approach fosters deeper procedural understanding.

Article

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Summary

ICH Q14 Implementation: Expert Panel Discussion on Analytical Method Development

BioQC Panel Q&A | PDF download | 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.

Summary

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

BioQC Panel Q&A | PDF download | 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.

Webinar

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.

Webinar

Analytical Quality by Design: Critical Analytical Procedure Parameters and Risk Assessments

BioQC 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.

Webinar

Analytical Quality by Design: Analytical Procedure Control Strategy (ACPS)

BioQC 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.

Webinar

ICH Q14 Analytical Procedure Development

BioQC On-Demand Presentation by Dr. Christof Finkler (F. Hoffmann-La Roche AG) | Understand the objectives and development history of ICH Q14, and learn how the minimal and enhanced approaches form a spectrum of increasing procedural understanding, lifecycle flexibility, and more suitably justified established conditions.

Expert Forum

Overcoming key challenges in understanding and implementing guideline ICH Q14 for Analytical Procedure Development

BioQC On-demand Presentation | Gain a comprehensive overview of ICH Q14 and understand the shifting regulatory landscape around analytical procedure development, including the balance between enhanced risk-based approaches and existing industry practices.

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