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COMPUTER SYSTEMS VALIDATION & DATA INTEGRITY INSPECTION READINESS

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November 25 - November 27

Cork, 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

More Information To Follow Soon

Faculty

  • Derek Foley, Senior Validation Engineer, Technical Operations, Janssen Sciences Ireland

    Mr. Foley is an experienced Engineer with over twenty years of experience in FDA/EMEA regulated biopharmaceutical, pharmaceutical and medical device industries. Derek has extensive experience in many areas of validation including; Process Validation, Cleaning Validation, CSV, Analytical validation and Validation of equipment/automated processes.
  • Fergal Giles, Technical Operations - Cleaning Validation Lead, Janssen Sciences Ireland

    Mr. Giles is an experienced validation lead with over fifteen years of experience in validation particularly cleaning validation. He has successfully completed complex validation projects within the biopharmaceutical industry.
  • Patrick T. O’Sullivan, Technical Operations, Janssen Sciences Ireland UC

    Patrick has been working in the area of Multivariate Analysis across Janssen’s Large & Small Molecule platforms with responsibility for Multivariate Analysis on the Cork sites. He continues to be an active member in the academic community guest lecturing on the area of advanced analytics and its place in the pharmaceutical and biopharmaceutical sector both today and in the future to Biotechnology & Data Analytics students.
  • Aidan Sexton, Technical Operations, Janssen Sciences Ireland UC

    Dr. Sexton is an experienced team leader with over twenty years of experience in all areas of validation including; process validation, facilities validation, analytical equipment, and cleaning validation. He has been active in leading intricate projects within the sterile fill finish, API and biopharmaceutical industry.

Sponsors

  • PLATINUM


  • 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
  • ecvalidation is a division of eConsulting company. We offer validation and qualification services of software, equipment, installations, rooms and processes. Our advantages are skills, knowledge and the qualifications of our team members. We have gathered vast experience through over 300 projects for clients from industries where quality assurance is of key importance. We also put a great emphasis on broadening our knowledge on new regulations, recommendations and best practices.
    Website: www.econsulting.pl
  • GOLD


  • Ecolab is the global leader in water, hygiene and energy technologies and services. Every day, we help make the world cleaner, safer and healthier – protecting people and vital resources.
    Website: https://www.ecolab.com/
  • For almost sixty years, Kaye has been at the forefront of high accuracy process measurement. For applications from thermal process validation and environmental monitoring, to sensor calibration, Kaye technology has provided the most accurate and user friendly measuring systems available in the market today.
    Website: https://www.kayeinstruments.com/en/
  • Consultancy and Training that Delivers a Measurable Return on Investment.
    Website: http://markthompsonls.com/
  • ROQMetrics is a Life Sciences CSV solutions and consulting firm with over 20 years of experience in global GxP compliance and technology. We offer innovative SaaS solutions to accelerate and elevate compliance of GxP applications using proven frameworks and methodologies. ROQMetrics helps with all aspects of validating computer systems from developing IT processes, SOPs, validation plans, risk assessment, test scripts, etc. ROQMetrics uses Lean-Agile practices to bring collaboration, continuous feedback, and improvement to the application lifecycle, resulting in more responsive and adaptive processes.
    Website: https://roqmetrics.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

    More Information To Follow Soon

Venue

Details

Start:
November 25
End:
November 27
Event Category:

Venue

Rochestown Park Hotel
Rochestown Road
Cork, Ireland
+ Google Map
Phone:
353 21 489 0800
Website:
https://www.rochestownpark.com/

Pricing & Registration

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