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September 22, 14:00 - 15:30 (UTC+2)

The pharmaceutical and medical device industry is experiencing a digital transformation driven by the need to enable efficient data sharing and automation in its manufacturing and distribution practices – typically by means of GxP systems. Ensuring regulatory compliance in this transformation is often challenging. There are practical, procedural as well as technical aspects to consider. During this webinar we’ll cover the following topics and use examples to give you an even better understanding on how to apply the requirements in your organization.

In this FREE webinar, Amin Gholiha will cover:

  • What is data integrity?
  • What is an audit trail?
  • How is data integrity managed?
  • Part 11 – Quick overview of the difficulties
  • Static and dynamic data / Open vs. closed systems
  • General Q&A

About the speaker

Amin Gholiha
Principal advisor, Data Ductus 

15+ years within pharma/medical with advanced IT/medical device/GxP solutions.


Date: 22 September, 2020
Time: 14:00-15:30
Cost: FREE

To participate in this webinar, please fill in the form below and press the Sign Up button. A confirmation email will be sent to the email address you register with.

Webinar: Practical data integrity (FDA Title 21 CFR Part 11)

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Event details
September 22, 14:00 - 15:30
Webinar: Practical data integrity (FDA Title 21 CFR Part 11)
Data Ductus