This webinar explores how the life sciences industry is navigating complex supply chain challenges driven by evolving regulations, rapid technological advancements, and shifting healthcare ...

The FDA’s Final CSA Guidance represents a significant step in modernizing validation across the industry. While it brings clarity, many questions remain about interpretation, practical application, ...

From CSA to digital transformation, our experts turn compliance into a competitive advantage. OCM bridges the gap between innovation and adoption—ensuring your workforce is ready when change occurs.

In this session, participants learn some of the newer digital capabilities that enable simulation for designing out manufacturing defects, enforcement to error proof ...

Since the release of the FDA draft on Computer Software Assurance (CSA), September 13th, 2023, many questions and concerns have been raised regarding the impact of the guidance on 21 CFR Part 11. The ...

The life sciences industry faces complex supply chain challenges that stem from regulatory and compliance shifts, fast moving technological advancements, and evolving healthcare expectations.

Join us for an insightful webcast exploring the transition from traditional Computer System Validation (CSV) to the modern, risk-based Computer Software Assurance (CSA) approach. This session will ...

This session will highlight into the evolving viewpoint on AI governance in MedTech. Learn how to align your strategies with current and upcoming regulatory expectations and prepare for regulatory ...

CSA draft guidance 2022 is Finally here – Join Compliance Group, FDA, and FICSA Team members for a series of webinars to clarify the Application of CSA in your organization ...

Explore the future of Computer System Validation (CSV) and Computer Software Assurance (CSA) at the KENX CSV & CSA University 2025, Hybrid Conference, a two-day program designed for professionals in ...