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.