Max Lazar is a recognized expert in this field. His more than 50 years of experience in the pharma industry included his career with Hoffmann-La Roche, Inc. from which he retired after 35 years with the firm. During that period he rose to Vice President, FDA and DEA Compliance and also was chair of various industry committees within PMA/PhRMA. Max was selected the Topic Leader for PhRMA to lead the development of the API GMP Document to be written by the ICH EWG. As a member of the ICH Expert Work Group (EWG), he was awarded the FDA’s Commissioner’s Special Citation: For his “outstanding cooperation and achievement in developing an internationally harmonized good manufacturing practice for active pharmaceutical ingredients”. Since retirement, he has been called upon to use his first-hand experience with API to consult and train firms and regulators on a proper application of API GMP.