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Continued Verification * Master Planning * Risk * Statistics * Change Control * Data Integrity

March 30, 2020 - April 1, 2020

Philadelphia, United States


Knowledge Exchange Network (KENX) is very excited to announce Validation University is returning to Philadelphia. The event is a dream come true for engineering, quality, C&Q and validation professionals by offering hands-on training for the pharmaceutical, biotech, medical device and related industries. Participants create-their-own-experience by choosing from over 40 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.  


40 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

  • Stay up to speed with FDA’s Computer Software Assurance proposed draft
  • 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.


This Conference is Co-Located with DATA INTEGRITY INSPECTION READINESS SUMMIT with In-Depth Coverage On:

  • Understand the Human Factor for Compliance
  • Learn How to Build a Program from the Ground Up
  • Identify the Root Cause of Inaccuracies
  • Conduct an Audit/Gap Assessment and Implement Corrective Action
  • Comply Across the GxP Environment
  • Benchmark With Manufacturing, Laboratory and Clinical Top Companies
  • Address Malicious Threats through Cybersecurity Best Practices
  • Conduct Data Integrity Risk Assessments
  • Know How to Handle Audit Trails




More Information To Follow Soon



  • Since 1949, Ellab is a leading manufacturer of a full line of wireless, real-time data loggers and wired thermocouple validation systems with temperature, humidity, pressure, vacuum, conductivity and CO2 sensor options. Additionally, Ellab offers temperature standards, calibration dry blocks and liquid baths, custom fittings, accessories, and thermocouples. We also offer on-site qualification, validation and calibration services for thermal validation processes ranging from -196°C to 400°C. Typical environments often include -80°C freezers, incubators, stability chambers, autoclaves, and ovens.
    Website: https://www.ellab.com/


    More Information To Follow Soon



March 30, 2020
April 1, 2020
Event Category:


Wyndham Philadelphia Historic District
400 Arch Street
Philadelphia, PA 19106 United States
+ Google Map
(215) 923-8660

Pricing & Registration

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