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COMPUTER SYSTEMS VALIDATION & Data Integrity Compliance Congress

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Governance | Compliance | Validation

November 19 - November 21

Dublin, Ireland

KENX Returns to Dublin in 2018!

Recent FDA Warning Letters Highlight CSV & DI Deficiencies

The FDA has issued many Warning Letters emphasizing CSV non-compliance. 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 comprehensive CSV& DI Congress is headed to Dublin and showcases the protocols, methodology and actions necessary to avoid regulatory action.

Choose from Over 15 Tutorials Addressing Today’s Top Challenges

 

Computer Systems Validation

  • Conduct a CSV Audit Enterprise-Wide and Develop a Master Plan
  • Perform Risk Assessments on Complex Systems
  • Understand Documentation Requirements for Validation
  • Confirm Accurate Processing, Control and Reporting of Electronic Records
  • Develop an Effective CSV Corrective Action and Preventive Action (CAPA) Program
  • Audit and Validate Paper, Electronic and Hybrid Systems
  • Streamline Processes with Innovative E-Validation Solutions
  • Write IQ/OQ/PQ Procedures, User Requirements and Test Scripts for New Systems
  • Learn Best Practices for Change and Configuration Management
  • Qualify Cloud Infrastructures & Mobile Devices
  • Understand How to Validate Excel™ Spreadsheets

 

Data Integrity Compliance

  • Develop, Implement and Maintain Data Integrity Protocols Enterprise-Wide
  • Learn the Methodology and Techniques Used to Identify Inaccuracies
  • Conduct an Audit Enterprise-Wide
  • Ensure the Reliability and Completeness of Analytical Data
  • Identify and Investigate Root Causes of Integrity Lapses
  • Know the Expectations for and Handle Issues in the Analytical Lab
  • Perform a Risk Assessment for Deficiencies
  • Understand Requirements and How to Handle Audit Trails

 

Personnel in the Following Environments Should Attend:

  • Validation
  • Quality Assurance
  • Engineering
  • IT
  • Quality Control
  • Manufacturing Management
  • Laboratory Management
  • Regulatory Affairs

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

Agenda

More Information To Follow Soon

Faculty

  • COMING SOON!

Sponsors

  • GOLD


  • Kneat Software

    Digitally Transforming GxP Validation Processes
    Website: http://kneat.com
  • SILVER


  • Novatek

    Novatek International provides a new breed of all-encompassing, process-driven LIMS and other software solutions that target the pharmaceutical, biotech and other health-care industries.
    Website: http://ntint.com/
  • ValGenesis

    Global Leader in Paperless Validation
    Website: http://www.valgenesis.com/
  • VTI Life Sciences

    Inspiring Operational Excellence through Best-in-Class CQV Processes
    Website: http://validation.org/

Partners

Venue

Details

Start:
November 19
End:
November 21
Event Category:

Venue

Dublin
Dublin, Ireland + Google Map

Pricing & Registration

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