CSV & CSA University Dublin

Join Us for the CSV/CSA University in Dublin, 10-11 June , 2025!

Experience two transformative days in the heart of Dublin, Ireland, at the CSV/CSA University event. This premier gathering of validation and compliance professionals will explore the latest innovations in Computer Systems Validation (CSV) and Computer Software Assurance (CSA), providing actionable insights to modernise your practices and address the challenges of today’s evolving technology landscape.

Whether you're looking to refine your traditional CSV approach or embrace groundbreaking innovations like AI and digitalization, this event will deliver essential knowledge, practical strategies, and expert-led discussions to elevate your validation processes.

Modernise Traditional CSV Practices: Trends and Strategies for Compliance and Efficiency

Explore how modern approaches are revolutionising traditional validation practices. Learn to streamline processes, enhance compliance, and align with evolving regulatory expectations. Session highlights include:

• Revolutionising CSV: Embracing CSA, Critical Thinking, Risk Analysis, and Cutting-Edge Tools
• Navigating the Regulatory Maze: Mastering Data Integrity, Annex 11/Part 11, CSA, and GAMP® 5
• Modernising CSV Training: Leadership Strategies and Innovative SOPs
• Risk-Based Approach to CSV: Simplifying Compliance for Better Results
• Qualifying SaaS and IaaS: Building Reliable Cloud Validation Processes
• Data Integrity Beyond ALCOA: Modernising Your Compliance Programmes
• CSA Implementation 101 – Industry Case Studies That Inspire Success

Transitioning CSV Through Innovation

Dive into the future of validation with innovative tools and strategies like AI, digital transformation, and predictive analytics.

• AI and Digital Transformation: Redefining Validation Strategies and Superintelligence Governance
• Digital Validation Tools: Harnessing Data Analytics and Predictive Modeling
• Case Studies in AI Validation for Regulated Environments
• Ensuring Compliance for AI-Driven SaaS and Cloud Systems
• Risk-Based Impact Assessments – Scripted vs. Unscripted Testing for Criticality
• Validate Big Data Effectively to Ensure Quality Across Complex Platforms
• Enhancing Validation Efficiency with AI-Driven Automation
• From Paper to Digital: Best Practices for Paperless Validation Programmes

What Past Attendees Are Saying

“The panel discussion on advancing CSA through digitization and generative AI was enlightening. I find the workshops are useful and the speakers are approachable. I wish that some workshops in the conference can be recorded and shared with the attendees for training purposes. I would recommend this conference to my peers. Thank you for the learning opportunity.”

- Quality Specialist, Johnson & Johnson

“Great in person Conference session with different participants from professional knowledge exchange network by great speakers about computer systems validation and software assurance.

This will have great impact on my career development and professional development, and I am so grateful to Temple university school of Ph*rm*cy for this opportunityThank you for the learning opportunity.”

- RAQA Student/Senior Manufacturing Tech, Johnson & Johnson

Who Should Attend

This event is designed for professionals in regulated industries who are involved in computer systems validation, quality assurance, regulatory compliance, and related roles, including:

• Validation and Quality Specialists
• IT and System Implementation Professionals
• Compliance and Regulatory Affairs Experts
• Engineers and Project Managers in GxP environments
• Senior Leaders Driving Digital Transformation

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