Product Review

This Advisory explains verification and validation from the perspective of a former senior FDA investigator. Now a consultant with EduQuest, a global team of FDA compliance experts, Denise Dion also has spent the past nine years looking at V&V from industry’s side, walking manufacturing floors, auditing product design labs, reviewing CAPA programs, and helping device makers understand the critical difference between verification and validation.

The Advisory is designed to help readers identify the most important regulatory expectations and clarify the gray areas that distinguish V&V either in reality or perception. Direct citations from regulations or guidance documents are included.