Kathy Gniecko is the Head of Quality Management Services, IT Quality at Hoffmann-La Roche, Basel Switzerland. She is responsible for Computer Systems Validation Policy at Roche, CSV SOPs within the Informatics organization and owns the Risk Assessment process for computerized systems. Kathy and her group perform training and coach project teams globally on the implementation of CSV within Informatics projects. She has also worked in the Pharma industry involved In the validation of manufacturing and IT systems as well as laboratory equipment. She was a co-leader of the first GAMP Lab Systems SIG and currently leads the GAMP Cloud SIG. Previous to her career in IT Quality, Kathy has worked in pharmaceutical QC and R&D laboratories . Kathy has a BS in chemistry from St Joseph's University.