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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.
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.
Opportunities and challenges from ICH Q2 (2) and Q14 for the analytical lifecycle
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.
Regulatory expectations for your HCP analysis: meet USP <1132.1> to enhance the quality of MS-based data
On-Demand Presentation | Incl. panellist from U.S. Pharmacopeia (USP) | Compare the pros and cons of the three HCP quantification methods outlined in USP 1132.1, and gain insight into how LC-MS/MS enables more specific identification and quantification of individual HCPs beyond what traditional ELISA approaches can provide.
Peak Integration of Electropherograms in GMP and Research Labs: Navigating Increased Scrutiny Amid Data Integrity Audits and Inspections
Meet the Expert: Dr. Timothy Blanc | Explore the current lack of regulatory guidance for electropherogram integration and discover how industry-wide harmonisation of guidelines, benchmarks, and software could strengthen analytical reliability.
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.
A Practical Approach to Implementing ICH Q14: Tools for Analytical Quality by Design in Capillary Electrophoresis Method Development
Meet the Expert: Dr. Ewoud van Tricht | Discover how capillary electrophoresis, developed using Design of Experiments, can replace slower techniques like qPCR for adenovirus quantification, cutting analysis time from days to under an hour.
Best Practices for Updating Analytical Procedures in Drug Development and Manufacturing
On-Demand Presentation | Learn the regulatory expectations for replacing or updating analytical procedures during drug development and manufacturing Understand the practice surrounding post-approval method changes and its impact on compliance Identify when pharmacopoeial methods are necessary and when alternative validated methods may be used Gain practical insights into testing comparability between methods and replacing existing methods or instrumentation
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.
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