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 ...

Safety and efficacy are the two regulatory benchmarks for pharmaceutical products. Microbial contamination of products is an important aspect of product quality that can affect both safety and ...

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

The key statistical objective in IVD device evaluation is establishing performance criteria while minimizing bias and maximizing precision. While the statistical considerations and methodologies ...

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, ...

Approved by the Royal Society of Chemistry for purposes of continuing professional development. This course will provide you with the requisite scientific knowledge and understanding of analytical ...

Analytical Method Validation work is based on a variety of guidelines and requirements hence being time-consuming and stressful. Reducing this work and improving efficiency while ensuring the highest ...

These methods hold out a small amount of training data, called validation data, and use it to assess the accuracy of the predictor. To find the root of the problem, they conducted a thorough analysis ...