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.