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lun. 27 nov.
|Amsterdam
Kenx Validation University Europe 2023
Knowledge Exchange Network (KENX) is extremely excited to announce Validation & GMP University is returning to Europe this November! This is Europe’s leading validation and QMS event. Do not miss this opportunity to network with leading experts and like-minded colleagues.
Registration is closed
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27 nov. 2023, 07 h 00 UTC+1 – 29 nov. 2023, 17 h 00 UTC+1
Amsterdam, Stadhouderskade 12, 1054 ES Amsterdam, Netherlands
À propos de l'événement
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
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