Practical data integrity (FDA Title 21 CFR Part 11)
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
Principal advisor, Data Ductus
15+ years within pharma/medical with advanced IT/medical device/GxP solutions.
Date: 22 September, 2020
WhenSeptember 22, 14:00 – 15:30 (+01:00)
- Amin Gholiha, Principal advisor, Data Ductus