Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Shiri Hechter, senior lab operations manager for Nelson Laboratories, provide a simple approach to validating ...
Dublin, Jan. 18, 2024 (GLOBE NEWSWIRE) -- The "Analytical Methods Validation for FDA Compliance Drugs and Biologics" training has been added to ResearchAndMarkets.com's offering. This Analytical ...
Dublin, Dec. 04, 2024 (GLOBE NEWSWIRE) -- The "Analytical Methods Validation for FDA Compliance Drugs and Biologics" training has been added to ResearchAndMarkets.com's offering. Dependable analytical ...
The data generated using analytical test methods is essential for many of the critical decisions made in the pharmaceutical industry. To be confident in the integrity of this data it is crucial that ...
Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...
The importance of getting buy-in from regulatory authorities early in the development process is critical in order to establish meaningful specifications. The words ‘method’ and ‘validation’ do not ...
In the pharmaceutical industries, validation of analytical methods is a critical process that confirms the reliability and appropriateness of a method for its intended application. Method validation ...