Webinar Archives - BioQC | Quality Experts

Webinar

Advertisement

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.

Opportunities and challenges from ICH Q2 (2) and Q14 for the analytical lifecycle

by BioQC Webinar

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.

Moving HCP LC-MS analysis into a GMP environment

by BioQC and Alphalyse Webinar

On-Demand Presentation | Learn directly from Alphalyse's CEO | Understand the basic requirements for implementing a GMP-compliant LC-MS method for host cell protein analysis, including key considerations for alignment with USP 1132.1 and ICH guidelines.

Regulatory expectations for your HCP analysis: meet USP <1132.1> to enhance the quality of MS-based data

by BioQC and Alphalyse Webinar

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.

LIMS as Part of the Application Landscape for Manufacturing

by BioQC Webinar

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

by BioQC Webinar

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

by BioQC Webinar

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

by BioQC Webinar

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.

Patient-Centric Specification Setting: Beyond Batch Data

by BioQC Webinar

On-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.

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

by BioQC Webinar

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.

Webinar

Advanced ELISA-MS™ for Host Cell Protein (HCP) coverage and ELISA Antibody Characterisation

BioQC and Alphalyse On-Demand Presentation | With experts from Alphalyse | Learn about the pros and cons of HCP ELISA coverage methods outlined in USP 1132 and 1132.1, and understand how ELISA-MS™ combines immunocapture with LC-MS to provide more accurate and specific antibody characterisation than traditional approaches.

Webinar

Opportunities and challenges from ICH Q2 (2) and Q14 for the analytical lifecycle

BioQC 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.

Webinar

Moving HCP LC-MS analysis into a GMP environment

BioQC and Alphalyse On-Demand Presentation | Learn directly from Alphalyse's CEO | Understand the basic requirements for implementing a GMP-compliant LC-MS method for host cell protein analysis, including key considerations for alignment with USP 1132.1 and ICH guidelines.

Webinar

Platform Analytical Procedures, beyond the technical challenges

BioQC 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.

Webinar

Regulatory expectations for your HCP analysis: meet USP <1132.1> to enhance the quality of MS-based data

BioQC and Alphalyse 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.

Webinar

LIMS as Part of the Application Landscape for Manufacturing

BioQC 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.

Webinar

The Role of LIMS in Integrated Manufacturing Environments

BioQC and LabWare 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.

Webinar

Using LIMS to solve key laboratory challenges

BioQC and LabWare 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.

Webinar

Explore the key success factors and implementation challenges in LIMS deployment

BioQC 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.

Webinar

Translating small-molecule development to complex generics and biosimilars

BioQC On-Demand Presentation by Dr. Joseph Glajch (JLG AP Consulting) | Explore the concept of fingerprint-like similarity in biosimilar development aand discover how orthogonal analytical methods applied across large reference product datasets can reduce residual uncertainty and influence the scope of clinical testing required.

Advertisement