Kenx Validation University Europe 2023

Choose from 50 Tutorials Overflowing with Rich Content and Tangible Takeaways, Including:

Process Validation

• Master Risk-based, 3-Stage Process Validation
• How to Drive a Risk-based IQ, OQ, and PQ Approach
• Critical Utility Qualification – HVAC, Water and Process Gasses

Cleaning Validation

• Establish Cleaning Residue Limits and Acceptance Criteria
• Learn How to Validate Visual Inspection Systems
• Hot Topics in Cleaning – Stainless Steel Equipment Maintenance and Air Liquid Interface Rings

Computer System Validation & Software Assurance

• Modernize Software Validation and Risk Assessments
• Tips for Transitioning Current CSV Program to Align with FDA’s Computer Software Assurance Guidance
• Critical Thinking and the CSA Movement – Rethinking Your Approach to Technology

Data Integrity Compliance

• Building and Managing a Data Integrity Program
• Data Process Mapping – Utilize an Innovative Tool to Manage Data Integrity
• Develop a Quality Culture that Minimizes Human Error and Data Integrity Lapses

Quality Metrics & Systems Management

• FDA’s Quality Metrics Movement – What You Need to Know to Get Started
• SOPs – Writing Quality Procedures that Survive the Lifecycle
• How to Increase and Achieve Right First Time Rates

Change Control & Risk Management

• Integrate Risk Management into Change Control Procedures
• Risk-Based Thinking – Maximize your ROI on Risk Assessments – A Practical, Resource Effective Approach to Risk Management
• Conducting Impact Assessments as Part of Change Control