Max Lazar graduated from Brooklyn College of the City University of New York where he majored in Chemistry.
From 1994 to 2001 Max Lazar was Vice President, FDA & DEA Compliance at Hoffmann-La Roche. In that position he was responsible for compliance oversight of all of the Roche USA businesses including Active Pharmaceutical Ingredients, Pharmaceuticals, R&D, Diagnostics, Fine Chemicals and Vitamins.
As a voting member of the ICH Expert Work Group (EWG) that developed and negotiated the ICH Q7 Guidance, Max Lazar is uniquely qualified to share and explain the EWG's intent of this new guidance. His involvement in this new API GMP predates the ICH activity itself.
For his contribution to Q7A, he was awarded the USA FDA Commissioner's Special Citation "For outstanding cooperation and achievement in developing an internationally harmonized good manufacturing practice guidance for active pharmaceutical ingredients used in human drug products."
He is author or co-author of the following chapter of GMP Compliance Adviser: