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 ...

Bioanalytical method development and validation are at the forefront of ensuring rigorous, reproducible and reliable data in both drug development and clinical diagnostics. The field encompasses the ...

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 ...

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

This webinar will discuss the distinction between and requirements for method validation and method verification, to comply with ISO/IEC Standard 17025:2005 for laboratory accreditation in food/water ...

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 ...

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 ...

This talk will focus on doing method validation work in an environment where data is gathered from laboratory information systems and chromatography data systems. We’ll see how these systems can be ...

Real world analysis of VTE incidence in lung cancer: A comprehensive assessment of the Khorana score and other clinical factors in predicting VTE incidence. This is an ASCO Meeting Abstract from the ...