SPECIAL PRICING: $1,295 IN-PERSON, $995 VIRTUAL
AGENDA
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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
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.
