Meeting date: November 19, 2024, 11:00 AM to 12:15 PM ET
Description:
Join us for an insightful webinar, “Preparing for FDA Inspections in a Digitalized Landscape: A CSA Perspective,” on November 19, 2024, from 11:00 AM to 12:15 PM (EDT).
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:
🎤Khaled Moussally: EVP, Corporate Development & Operations, Compliance Group Inc
🎤 Daniel Walter: Policy Analyst, FDA
🎤 Ken Shitamoto: MS-Executive Director-IT, Quality & Compliance, Gilead Sciences
🎤Roy Devine: GPO-Computer System Validation, BD
🎤Margaret Hindley MBA, PhD, CQA, CQE: Director-Computer Software Assurance, Taiho Oncology, Inc.