Beyond GMP: Selecting and Managing CDMOs for Biological Products
16 September 2026
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
Addressing Challenges in Analytical Validation: Understanding ICH Q2(R2) and Integration with ICH Q14
On-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.
Recent Advances in Process Analytical Technology (PAT) for Downstream and Upstream Processing
Upcoming | Obtain an overview of common analytes and analytical techniques used as PAT for cell culture/fermentation and purification.
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.
Setting Biopharmaceutical Specifications: Navigating Regulatory Requirements in Accordance with ICH Q6B
On-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.
Overcoming key challenges in understanding and implementing guideline ICH Q14 for Analytical Procedure Development
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.
LIMS as Part of the Manufacturing Application Landscape
On-Demand Presentation | Understand how modern LIMS function as the central hub of laboratory automation and data integrity, supporting compliance with ALCOA+ principles across development and quality control environments.
CMC: A Developmental Approach to Ensure Drug Quality – from Small-Molecule Drugs to Biotherapeutics
On-demand Presentation | Understand the key differences in CMC processes, quality attributes, and testing methods between small-molecule drugs and biotherapeutics, including contrasts in manufacturing, purification, and regulatory expectations.
Understanding The Difference Between Small-Molecule Drugs And Biotherapeutics
On-Demand Presentation | Explore how quality control principles and analytical characterisation strategies evolve across drug modalities and learn what does and does not translate when moving between small-molecule and biological drug development.
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