Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.

The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides ...

This course will provide you with the requisite scientific knowledge and understanding of analytical method lifecycle management, which includes the activities of validation, verification, transfer, ...

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...

New research paper titled “Supervised Learning for Coverage-Directed Test Selection in Simulation-Based Verification” from researchers at University of Bristol and Infineon Technologies. “Constrained ...

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The most probable number (MPN) bioburden test method can be a valuable tool for determining bioburden counts when the typical bioburden test methods are problematic on a particular product or when a ...