BioQCExpert 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.
BioQCOn-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.
BioQCExpert 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.
BioQCOn-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.
BioQCOn-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.
BioQCOn-Demand Presentation by Dr. Simona Cianetti (GSK) | Understand the principles of patient-centric specification setting and learn how clinical exposure data, process characterisation, and modelling can be combined to establish clinically justified acceptance criteria that go beyond batch data and manufacturing variability.
BioQCOn-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.
BioQCOn-Demand Presentation by Dr. Patanachai “Kong” Limpikirati (Chulalongkorn University) | Learn how to construct a comprehensive specification framework for monoclonal antibodies under ICH Q6B, covering the five core quality attribute categories and understanding which tests belong in drug substance versus drug product specifications.
BioQCOn-demand Presentation | Gain an overview of ICH Q6B and current practices for setting specifications for biopharmaceuticals, including monoclonal antibodies and advanced therapies, and understand the statistical and analytical considerations involved.
BioQCExpert 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.
