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 ...

Method validation is an essential part of establishing and ensuring the quality of analytical data. It cannot be guaranteed that data will be fit for purpose unless the performance of the test method ...

This course will provide you with the requisite scientific knowledge and understanding of analytical method validation, verification, and transfer to allow informed interpretation of current ...

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process. The US Pharmacopeial Convention (USP) released a general ...

Computerized systems are those which comprise the components shown in Figure 1.1, namely, a computer system and a controlled function which is operating within its specified working environment. The ...

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

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 ...

DUBLIN--(BUSINESS WIRE)--The "Analytical Method Validation, Verification and Transfer Virtual Seminar (Oct 7th - Oct 9th, 2025)" has been added to ResearchAndMarkets.com's offering. Dependable ...

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 ...

Clinical development of new anticancer drugs can be compromised by a lack of qualified biomarkers. An indispensable component to successful biomarker qualification is assay validation, which is also a ...