CAI









VALIDATION UNIVERSITY COMES TO AMSTERDAM!

Attend in Amsterdam!

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 leading the charge for best practices in validating processes, cleaning, equipment, facilities, utilities, quality systems & metrics, change control, risk management, inspections and so much more! Participants can create their own experience by choosing from over fifty tutorials and benefit from the wealth of knowledge that will have immediate impact on their professional development and organizations.

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

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.

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