Ken Shitamoto, Member of FDA Industry CSA (FICSA) and GAMP Americas’ Steering Committee

---

Ken Shitamoto is a technology and quality leader with more than 30 years of experience in the pharmaceutical industry, including roles at Genentech, United Biosource Corporation, and Gilead. His work focuses on modernizing quality and validation practices for regulated computerized systems, emphasizing risk-based approaches and software quality engineering.

Ken actively contributes to the global industry through organizations such as the FDA Industry CSA (FICSA) team and the GAMP Americas Steering Committee. As a member of FICSA and co-lead of GAMP’s Computer Software Assurance Special Interest Group, he is helping advance the practical implementation of modern assurance and validation practices. He has also contributed to industry guidance publications including GAMP 5 Second Edition, Enabling Innovation, and Data Integrity by Design.