KENX Validation University 2025

An event for QA, Validation, Engineering, IT, and RA professionals working in the pharmaceutical, biopharmaceutical, and medical device industries.

Highlighted Sessions:

• Modernizing Process Validation: Strategies for Stage 1-3 Compliance and Efficiency
• CSV 4.0: Validating AI, SaaS, and Cloud-Based Systems
• Continuous Validation: Staying Compliant in Rapidly Evolving Environments
• Next-Gen Cleaning Validation: Integrating Risk-Based Approaches and Visual Inspection
• Risk-Based Approach to Computer Systems Validation: Simplifying Compliance
• Facility Qualification: Ensuring Regulatory Compliance Through Effective Design and Execution
• Quality Risk Management (QRM): Integrating ICH Q9 into Validation Processes
• Automated Validation Systems: Reducing Human Error and Increasing Efficiency

Trends:

• Computer Software Assurance (CSA): Shifting from Compliance to Critical Thinking
• Validation in Continuous Manufacturing: Ensuring Compliance in Real-Time Processes
• Lean Validation: Driving Efficiency and Reducing Costs in Complex Projects
• Data Integrity Beyond ALCOA: Addressing Current Challenges in Digital Validation
• Validation Master Plans: Blueprinting Success for Compliance and Efficiency
• Single-Use Systems in Validation: Balancing Flexibility and Compliance
• Audit Trails: Ensuring Data Integrity in a Digital Era