FDA CDER Bioanalytic Methods Validation Guidance

This guidance for those involved in Drug application (INDs, ANDAs) provides guidance for methods validation. It mentions software platform changes as a possible reason for partial validation:
“Partial validations are modifications of already validated bioanalytical methods. Partial validation can range from as little as one intra-assay accuracy and precision determination to a nearly full validation. Typical bioanalytical method changes that fall into this category include, but are not limited to:
Changes in instruments and/or software platforms”.

The full guidance is at the link provided.

SoftwareCPR keywords: software, drugs, pharmaceuticals, NDA, IND, CDER,

FDA and 62304 Training – Boston – June 4-6, 2019

3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.  John F. Murray, Jr., will be among the faculty!
The discounted April registration expires on April 30, 2019, or when all discounted seats are sold.

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.