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Process Mapping * Gap Analysis * CAPA * Human Factors * Program Management

March 30, 2020 - April 1, 2020

Philadelphia, United States

FDA Warning Letters Highlight Data Integrity Deficiencies


Data Integrity remains the life science industry’s greatest challenge as Warning Letters continue to rise year-over-year. These serious findings include; having interrupted, missing, deleted and lost data; inadequate records for risk analysis; failure to exercise appropriate controls; failure to validate computer software; failure to establish validation procedures; manipulation and deletion of audit trails; and many more. The time has never been more critical to evaluate and ensure your organization has top-notch compliant procedures. KENX is pleased to announce that our Data Integrity Inspection Readiness Summit is headed to Philadelphia to showcase the protocols, methodology and actions necessary to avoid regulatory action.


Be Prepared for the FDA Inspection Headed to Your Facility Soon!

  • 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


Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • Data Integrity and Document Management
  • Regulatory Affairs
  • Manufacturing, Laboratory and Clinical Management


This event is also appropriate to business development and sales managers that offer innovative solutions for data integrity, validation, quality and data collection environments.


This Conference is Co-Located with VALIDATION UNIVERSITY with In-Depth Coverage On:

  • Process Validation and Continued Process Verification
  • Cleaning Validation & Critical Cleaning Processes
  • Facility and Equipment Qualification
  • Critical Utility Qualification – HVAC, Water and Gas
  • Computer Systems Validation


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

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