Flavio Kawakami

Flavio Kawakami is a seasoned quality and compliance professional with over two decades of experience in the pharmaceutical and life sciences industries. A dedicated ISPE member since 2001, Flavio has contributed extensively to the development and review of GAMP® 5 guidance and currently serves as certified trainer for GAMP®. He is recognized for his expertise in computerized system validation, regulatory compliance, and the application of GAMP® principles to emerging technologies, including AI and cloud-based systems. Flavio has participated in multiple international GAMP® initiatives and conferences, where he shares insights on validation strategies and quality risk management in regulated environments. His work supports the advancement of best practices for digital transformation in GxP systems, helping organizations align with global regulatory expectations.
Working for several Fortune Global 500 companies such as Asea Brown Boveri, Magneti Marelli, Philip Morris, Kraft Foods and Wyeth, a great experience on process automation, ERP implementation and IT infrastructure management has been acquired. With a passion for knowledge transfer, Flavio is a recognized instructor in several institutions in Brazil and delivers technical content for the pharmaceutical professionals inside and outside ISPE. Volunteer for the Brazilian Agency ANVISA delivering training for auditors.