Practical Data Integrity (FDA Title 21 CFR Part 11 & EU Annex 11)

Presented by

Amin Gholiha, Principal Advisor, Data Ductus

About this talk

In this webinar our pharmaceutical and medical device industry expert Amin Gholiha walks you through parts of EU Annex 11 and FDA Title 21 Part 11 and how to ensure compliance. There are procedural, practical as well as technical aspects to consider that Amin illustrates by using real life examples. Topics covered: - 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 - Q&A Read about our services at:

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