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

MS, Sr. Director IT, Gilead Sciences


Ken Shitamoto is the Executive Director of IT Quality and Compliance at Gilead Sciences, which oversees IT Quality Engineering, Privacy, and Quality Assurance.  He is a member of the GAMP Americas Steering Committee, co-leads the Computer Software Assurance (CSA) Special Interest Group, and member of the FDA-Industry CSA team. His work includes contributions to the GAMP Good Practice Guides, such as Data Integrity by Design and Enabling Innovation, as well as GAMP 5 version 2.

He holds a Bachelor of Arts in Molecular Cell Biology from the University of California, Berkeley, and a Master of Science in Computer Science from San Jose State University.  Ken is also a Lean Black Belt, Certified Information Systems Security Professional (CISSP), Certified Information Systems Auditor (CISA), Certified Information Privacy Technologist (CIPT), Certified Tester Foundation Level (CTFL), Certified Professional for Requirements Engineering (CPRE), and Project Management Professional (PMP)

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