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On-Demand Webinars

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NVR Reconciliation – Expectations versus Reality

Non-volatile residue provides important information for the exhaustive extraction process. What are the expectations from regulators on the reconciliation between...

Designing a Biocompatibility and Chemical Characterization Strategy for a Device Portfolio with varying Risk Levels

This presentation delves into the intricacies of creating a robust biocompatibility and chemical characterization strategy tailored to a diverse device...

Looking into the Future of Extractable testing to support Chemical Characterization: What can we learn “Non-Targeted Analysis”Approaches and Practices applied in other Industries

It has now been more than 3 years ago since the adoption and implementation of the new ISO 10993-18 standard...

Current and Novel Approaches in the Quantitation Strategy for Results of a Non-Targeted Screening Analysis: implications for the AET calculation.

Extractables and/or leachables from medical devices must be identified and quantified to establish their potential effect on patient health and...

Container Closure Integrity Testing (CCIT) for Pharmaceutical Sterile-Barrier Packaging

Container closure integrity testing (CCIT) is used to evaluate pharmaceutical packaging, such as vials, syringes, auto injectors, and IV bags...