Implementing CSA for GxP Systems - Transition, Documentation, and Post-Transition Challenges and Opportunities

Description

The transition to Computer Software Assurance (CSA) marks a pivotal shift in the approach to compliance for FDA-regulated industries. This two-day seminar, "Implementing CSA for GxP Systems - Transition, Documentation, and Post-Transition Challenges and Opportunities," is designed to guide professionals in understanding the strategic and technical aspects of CSA implementation. With a focus on transitioning from the traditional Computer System Validation (CSV) methodology, the seminar covers risk-based validation, iterative approaches like Agile, and the integration of CSA principles into quality management systems (QMS).

Participants will explore how CSA enhances compliance by prioritizing critical thinking, risk-based assessments, and automation. The seminar delves into documentation strategies, continuous validation techniques, and overcoming post-transition challenges such as data integrity and regulatory communication. Attendees will also gain insights into leveraging CSA opportunities to optimize software quality, reduce validation costs, and ensure alignment with FDA’s expectations. This comprehensive program equips you with actionable knowledge and…