Ivan Soto is the Senior Manager of Validation, with Amgen. Under his leadership, his team has successfully implemented a lean validation program for the qualification of computer systems. Soto is a member of the Validation Academy guidance committee. Ivan Soto has been in the industry more than 20 years in various roles of Quality Control, IS Compliance, Laboratory Automation, Assay Development and Validation and 18 years specializing in Computer System Validation using GAMP methodology. Soto has a (B.S) in Chemistry from the Catholic University of Puerto Rico.