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mar. 28 mars


The DoubleTree by Hilton

KENX Validation University Conference

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.

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KENX Validation University Conference
KENX Validation University Conference

Heure et lieu

28 mars 2023, 07 h 00 HAE – 30 mars 2023, 17 h 00 HAE

The DoubleTree by Hilton, Hotel, 237 S Broad St, Philadelphia, PA 19107, USA

À propos de l'événement

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

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