Compliance Group is excited to participate in the KENX CSV & CSA University Conference 2026, bringing practical industry expertise to the evolving landscape of Computer System Validation (CSV), Computer Software Assurance (CSA), and AI-driven compliance.
We are proud to be a Gold Sponsor for this event.
The Early Bird offer ends November 6, 2026! Register early to take advantage of the $200 discount using promo code CG200 at registration.
As AI adoption accelerates across life sciences and other regulated environments, organizations must rethink traditional validation approaches, strengthen data integrity, and establish effective governance and oversight.
Join Compliance Group and fellow industry professionals in San Diego or virtually to explore practical strategies for advancing risk-based assurance, continuous validation, and AI system inspection readiness.
Featured Sessions by Compliance Group :
Session 1: Auditing AI Systems – What FDA Will Ask When They Inspect Your AI System: Documentation, Traceability & Decision Audit Trails
Session Date & Time: Thursday, December 10, 2026, | 12:20 PM – 1:00 PM
Speakers:
- David DeLuca, Director, Strategic Consulting, Compliance Group
- Benjamin Duncan, Engineering Manager, Design Assurance, Compliance Group
Move beyond inspection prep checklists and understand the specific questions FDA inspectors are asking about AI systems right now and exactly what documentation, traceability, and human oversight evidence they expect to see.
Session 2: Continuous Validation – Building a Validation Center of Excellence with CSA & Continuous Validation Practices
Session Date & Time: December 10, 2026, | 2:30 PM – 3:10 PM
Speakers:
- David DeLuca, Director, Strategic Consulting, Compliance Group
- Lakshmi Chitrapu, Associate Director, Quality Assurance IT Validation, Cytokinetics
- Benjamin Duncan, Engineering Manager, Design Assurance, Compliance Group
Driving efficiency and compliance through CSA-enabled continuous validation: governance model, KPIs, center of excellence structure, and lessons learned from US organizations.
Who Should Attend?
This conference is designed for professionals responsible for validation, quality, regulatory compliance, and digital transformation in regulated industries, including:
- CSV & CSA professionals
- QA and QMS leaders
- Regulatory Affairs and Compliance professionals
- IT Quality, GxP, and computerized systems specialists
- Validation engineers and Validation Center of Excellence leaders
- Data Integrity and Information Security professionals
- AI Governance and Digital Transformation teams
- Professionals responsible for regulatory audits and inspection readiness
Meet Compliance Group at AI in GxP 2026
Whether you are modernizing an established validation program, implementing risk-based assurance, or preparing your organization for AI adoption, CSV & CSA University 2026 offers opportunities to gain practical insights and connect with industry peers.