Hot Topic Seminar: Electronic Systems and Data Integrity in GxP

Are you updated on requirements and frequent deviations on electronic systems in GxP?

  • TBD

1 day course

English

2.500,- DKK ex VAT
(app. 336,- EUR ex VAT)

At the moment there are no available dates for this course.

This seminar is from 14.00 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.

Systems to support these ways of working can range from manual processes with paper records to fully computerised systems. Despite the work process, the regulatory requirements remains the same, i.e. having confidence in the quality and the integrity of the data generated (to ensure patient safety and quality of products) and you must be able to reconstruct activities.

At this hot topic seminar the Danish medicines inspectors will help you understand the principles of data integrity in GxP. We will look into some of the typical IT inspection findings and discuss the relevant corrective and preventive actions.

This hot topic seminar is the first of two. On 18 December 2018, we will look deeper into how to comply with data integrity in Good Clinical Practice. Click here to read more

Keywords

GxP
Data integrity
Electronic systems and data
IT inspection findings
Inspection deviations

What you will learn

  1. What the current requirements on electronic systems and data are
  2. What the typical IT inspection findings are
  3. How you minimize the risk of significant inspection deviations in relation to data integrity issues with electronic systems

What your company will get

  1. What the current requirements on electronic systems and data are
  2. What the typical IT inspection findings are
  3. How you minimize the risk of significant inspection deviations in relation to data integrity issues with electronic systems

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

 

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