Sponsorship Inquiry

AGENDA

SPONSORS



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CAI

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




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Ellab

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/




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CIMCON Software

CIMINFO’s LabMonitor software brings legacy lab applications into Part 11 compliance. Other solutions include Part 11 controls for Spreadsheets, Document and Quality Management, Training and an Inventory System for data integrity assessments. With over 20 year of experience, CIMINFO products are trusted by hundreds of FDA-regulated firms in over 30 countries. Website: https://part11solutions.com/
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Kneat

Kneat Solutions’ feature rich paperless validation platform, KneatGx™ makes validation easier, faster and smarter.  Purpose built for life sciences, KneatGx™ digitizes your entire validation life-cycle, enabling validation teams to author, review, approve, test-execute, manage exceptions and post-approve any business process in a 21 CFR Part 11 compliant web based software that’s securely accessible anywhere with an internet connection.
Website:  www.kneat.com
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Novatek International

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/
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QACV

QACV offers comprehensive quality assurance, compliance, and computer validation consulting services to meet your regulatory needs. We provide professional consulting services to FDA regulated life science industries and use proven methodologies to achieve sustainable compliance for your organization. Website: http://www.qacvconsulting.com/

CSV & Data Integrity Compliance Congress Returns to Dublin!


Attend Virtually or in Dublin, Ireland!

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.

Pricing & Registration

For An Additional $995, You Can Earn 1.5 Graduate Credit Hours Towards Temple’s RAQA Graduate Program! For More Information, Email INFO@KENX.ORG, Call 856-281-7134 or Register Above.