Tuesday, November 19, 2024
11AM – 12:15 PM EST

Presented by:

Ken Shitamoto
MS, Sr. Director IT
Gilead Sciences

Khaled Moussally
Executive Vice President, Corporate Development & Operations
Compliance Group

Daniel Walter
Policy Analyst
FDA

Margaret Hindley, Ph.D.
CQA, CQE, Director CSA/IT
Taiho Oncology

Roy Devine
GPO Computer System Validation
BD

The panelists of this webinar will focus on the evolving challenges and strategies for organizations to prepare for FDA inspections, especially as they increasingly implement digital technologies. In our regulated life science industry, digital transformation is reshaping validation, compliance, and quality assurance processes. Computer Software Assurance (CSA) offers a modernized approach, emphasizing risk-based validation rather than exhaustive documentation. This shift means organizations need to rethink how they demonstrate compliance and quality, especially under FDA scrutiny.

SPEAKERS

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.

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