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COMPUTER SYSTEMS VALIDATION & DATA INTEGRITY INSPECTION READINESS

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November 16 - November 18

Virtually or in Dublin, Ireland

MHRA Releases Final Data Integrity Guidance

 

MHRA, FDA and many other global regulations have issued many guidance’s regarding Data Integrity. How does one navigate this maze? Moreover, as data integrity matures and malicious threats have become commonplace, what do you do next? How do you manage your entire DI and Computer Systems Validation programs; governance, human errors, cloud computing, network infrastructures, auditing, and identifying and responding to gaps? 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 returning to Ireland and showcases the protocols, methodology, and actions necessary to avoid regulatory action.

 

Choose From Over 20 Tutorials Addressing Today’s Top Challenges

 

Computer System Validation

  • Cybersecurity – Addressing Malicious Threats to the Life Science Industry
  • Master the Key Components to Build and Maintain an Inspection-proof Program
  • Discover a GDPR Compliant Approach for SAAS, IAAS, and Other Software Services
  • Develop an IT Infrastructure and Network Qualification Roadmap

Data Integrity Compliance

  • Construct a Program from the Ground Up
  • Prepare for and Perform a Data Integrity Audit
  • See Remediation Projects and How to Build for the Future
  • Know How to Respond to Data Integrity Inspection Findings

AND MUCH MORE!

 

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 for business development and sales managers that offer innovative solutions for quality departments, validation departments, data collection, and statistics.

Agenda

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Faculty

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Sponsors


  • Fundamentally we exist for one reason: To accelerate our clients’ path to success. Our approach is simple; we put the client’s interests first. We don’t stop until it’s right. And we’ll do whatever it takes to get there.
    Website: https://commissioningagents.com

  • 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/

  • 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. Our unique portfolio of out-of-the-box, easy to use software solutions features specialized modules that help you manage all aspects of your quality environment with less effort and time. Novatek delivers solutions that go beyond LIMS for total enterprise wide automation.
    Website: https://ntint.com/

Partners

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Venue

Details

Start:
November 16
End:
November 18
Event Category:

Venue

Virtually or in Dublin
Virtually or in Dublin, Ireland + Google Map

Pricing & Registration

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