2017 FDA Data Integrity for Computerized Systems Seminar by GlobalCompliancePanel

  • 209.00 Dollar US$
  • Published date: February 16, 2017
    • Mumbai, India

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?
I often refer to 21 CFR 11 and Annex 11 as Good Software Engineering with the Documentation on Steroids! However, unless one knows how to implement Data Integrity, it is often very hard to apply requirements for DATA INTEGRITY to computerized system, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the agencies have stepped up data integrity inspections and the number of citations on the subject is skyrocketing!
This course is appropriate for beginner and experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy for yourself while still achieving data integrity.

Location: Mumbai, India Date: April 27th & 28th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: The LaLiT Mumbai
Address: Sahar Airport Road, Andheri East, Mumbai - 400059


Register now and save ₹ 2000. (Early Bird)

Price: ₹ 14,000 (Seminar for one Delegate)

Until March 25, Early Bird Price: 14,000 From March 26 to April 25, Regular Price: 16,000
Registration Details:
NetZealous - GlobalCompliancePanel
NetZealous Services India Pvt. Ltd.
Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar,
Bangalore - 560078 Karnataka, INDIA
Phone: 1800 425 9409
Fax: 080-25149544
Registration Link – https://www.globalcompliancepanel.in/control/FDA-data-integrity-21-CFR-11-Mumbai?channel=mailer&camp=seminar&AdGroup=science-marketplace.org_APR_2017_SEO
Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanelindia

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John Robinson
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