VALIDATION UNIVERSITY

March 28 – 30, 2023

Join KENX for hands-on training for engineering, quality, C&Q and validation professionals within the pharmaceutical, biotech, medical device and related industries. Participants can create-their-own-experience by choosing from over 55 tutorials and benefit from the wealth of knowledge and useful material our faculty exchanges. Val-U offers a hands-on experience in which lessons learned turn into immediate, actionable results.

Join KENX at industry’s validation event of the year! Whether you’re in QA, validation, or engineering; a novice or advanced professional; or, attending in-person or online, this is your chance to network with over 200 of like-minded colleagues in the FDA-regulated environment.

55 Tutorials Overflowing with Rich Content and Tangible Takeaways for the CQV Universe

Facility Commissioning & Equipment Qualification

• Implement a Risk-based Verification Strategy
• Design a Risk-based IQ, OQ, and PQ Approach
• Manage Process Validation Tech Transfers
• Qualify Critical Utility Systems – HVAC, Water and Gas

Process Validation

• Learn How To Use Statistics in Validation – Statistics for Non-Statisticians
• Implement a 3-Stage Process Validation Approach
• Master the Validation Master Plan (VMP)
• Conduct Risk-based Continued Process Verfications

 Cleaning Validation

• Understand Key Elements to a Successful Program
• Establish Cleaning Residue Limits and Acceptance Criteria
• Establishing Bioburden and Endotoxin limits for Sterile and Non-sterile Products and Processes
• Receive a Cleaning Validation Assessment Checklist Example

 Computer System Validation

• Modernize CSV Programs with FDA’s New CSA Guidance
• Implement a Risk-Based CSV Program Enterprise-Wide
• Develop and Validate SAAS, IAAS, and Other Software Programs
• Qualify Network Infrastructure and Cloud Environments

Advanced Validation Practices

• Applying Quality Metrics to Validation
• Critical Thinking – Understand How to Develop Critical Thinking Skills
• ICH Q10 Pharmaceutical Quality System, Section 2 – Mastering Management Responsibilities
• Continuous Process Validation and Holistic Control Strategy – Thinking Beyond CPP-Based Critical Aspects

Interested in attending specific advanced sessions? Click here for our brochure.

Personnel In The Following Environments Should Attend:

• Validation
• QA/QC
• Engineering
• C&Q
• Regulatory and Compliance
• Facility Management
• Manufacturing
• Laboratory

This event is also appropriate for business development and sales managers that offer innovative solutions for quality, validation and engineering professionals in the life science environment.