Hands-on experience on Data Integrity and Validation of Computer systems

Learn how you can comply with the requirements for electronic systems in GxP, and how to implement valid IT systems

  • 28. Mar 2019

1 day course

English

5.400,- DKK ex VAT
(app. 726,- EUR ex VAT)

This seminar is from 09.00 to 17.00.

Summary

The way regulatory data is generated has continued to evolve in line with the ongoing development of supporting technologies. Today we see an increased use of electronic data capture, automation and remote technologies. We also experience more complex supply chains and new ways of working, for example, via third party service providers. Organizations are expected to implement, design and operate a documented system that provides an acceptable state of control, based on the data integrity risk with supporting rationale.

This workshop will give a hands-on insight into GxP data integrity that is to ensure that data generated by computerized systems is complete, consistent and accurate. We will go through the regulators’ requirements and discuss how those requirements can be implemented in computerized systems.

We will describe the life cycle from data generation to archiving of regulated data with real-world examples from both small and big computerized systems. Finally, we will discuss challenges and common mistakes by looking at warning letters and observations and address how the authorities expect us to address issues by implementing controls, establishing processes and train those who work with computerized systems and have impact on regulated data.

This hot topic seminar has been prepared in collaboration with NNIT A/S and is the third in a line of three Hot Topics all focusing on electronic systems and data integrity. 

On 29 November 2018, we looked into the broad perspective of data integrity in GxP and on 18 December 2018 how to comply with data integrity in Good Clinical Practice.



 

Keywords

Data Integrity
Electronic systems and data
ALCOA
Critical Process Parameters (CPP)
IT Systems
Risk Assessment
IT-inspection findings
Validation

What you will learn

  1. How you make sure that correct and valid data will be generated by electronic systems
  2. How to review data and audit trail
  3. How risk assessment can help to focus on the critical issues and reduce the amount of work needed
  4. Why data governance is a key aspect of data integrity
  5. How to define roles and responsibilities to address requirements for data integrity as part of the Quality Management System (QMS)

What your company will get

  1. A professional who understands how to make sure that correct and valid data will be generated by electronic systems
  2. A professional how can review data and audit trail and who knows how risk assessment can help to focus on the critical issues and reduce the amount of work needed
  3. A professional who knows how to define roles and responsibilities to address requirements for data integrity as part of the Quality Management System (QMS)
Available start dates

Registration quick facts

You can pay by credit card or by invoice. We charge the amount shortly after you register. If you cancel your registration more than 30 days prior to the course, you will receive a full refund. Read our cancellation policy.

Yes, if you experience any technical problems, please call us at + 45 39 27 60 60, or send us an email at contact@atriumcph.com

If you cancel your registration more than 30 days prior to the course, you will receive a full refund. If you get sick on the day of the course, you can hand over your seat to a colleague. To hand over your seat, please contact us at +45 39 27 60 60. Read our cancellation policy.

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Programme Director Gitte Hornemann Møller at +45 39 15 09 20

Send an email

 

You may also be interested in these courses