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Seminar on FDA Data Integrity for Computerized Systems in Mumbai

Event Details

Seminar on FDA Data Integrity for Computerized Systems in Mumbai

Time: April 27, 2017 at 9am to April 28, 2017 at 6pm
Location: The LaLiT Mumbai
Street: Sahar Airport Road, Andheri East, Mumbai - 400059
City/Town: Mumbai
Website or Map: https://www.globalcompliancep…
Phone: 1800 425 9409
Event Type: seminar
Organized By: NetZealous - GlobalCompliancePanel
Latest Activity: Feb 20, 2017

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Event Description

Overview:

The Problem:

We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following?

  • Evolution of 21 CFR Part 11 and Annex 11 and Why they are Back in the News
  • Overview and Key Requirements of Part 11 & Annex 11
  • How to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance?
  • How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity?

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