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Analytical Method Comparability Studies: Expert Panel Discussion on Instrument and Technology Changes
Expert Insight & Answers | Understand the practical distinctions between comparability, equivalence, and equality in the context of analytical method transitions, and learn how to frame study objectives and acceptance criteria accordingly.
LIMS as Part of the Application Landscape for Manufacturing
On-Demand Presentation by Paul Shrevel (Solution Too) | Understand how LIMS fits within the broader ISA-95 manufacturing application landscape, connecting laboratory workflows to ERP, QMS, and supply chain systems, and recognise the data integrity risks associated with local instrument data storage.
Explore the key success factors and implementation challenges in LIMS deployment
On-Demand Presentation by Ramon de Groot (Limes Lab Support) | Understand how modern LIMS enforces ALCOA+ principles and has evolved from basic sample tracking into a central laboratory data management platform integrating with instruments, ELN, and ERP systems.
Beyond Accuracy and Precision: Total Analytical Error and Linearity in ICH Q2 Revision 2
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.
Statistically Sound Specification Setting – A Practical Approach Consistent with ICH Q6B and Q14
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.
The Role of LIMS in Integrated Manufacturing Environments
On-Demand Presentation by Jon Walker, LabWare | Explore what a well-designed LIMS ecosystem looks like in practice, and gain a realistic perspective on the current limitations and future potential of AI and machine learning tools within laboratory informatics environments.
Using LIMS to solve key laboratory challenges
On-Demand Presentation by Melanie Clark, LabWare | Understand how LIMS establishes end-to-end sample traceability, enforces ALCOA+ principles, and addresses regulatory compliance gaps through audit trails, electronic signatures, and automated out-of-specification alerts.
Beyond Sample Tracking – LIMS as the Backbone of Laboratory Data Integrity
On-Demand Presentation | Understand how LIMS have evolved from basic sample tracking to comprehensive digital data management systems, and learn how they support ALCOA+ compliance, audit-ready traceability, and GxP-compliant laboratory operations.
Capillary Electrophoresis (CE) versus quantitative Polymerase Chain Reaction (qPCR) for direct quantification of intact adenovirus particles
On-Demand Presentation by Dr. Francisca Galindo Garre (Johnson & Johnson Innovative Medicine) | Compare qPCR and capillary electrophoresis head-to-head and gain the statistical toolkit, from equivalence testing to correlated variance regression, to make defensible method interchangeability decisions.
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