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lun. 27 nov.



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.

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Kenx Validation University Europe 2023
Kenx Validation University Europe 2023

Heure et lieu

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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