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GlobalCompliancePanel is conducting a seminar on FDA Data Integrity for Computerized Systems

Event Details

GlobalCompliancePanel  is conducting a seminar on  FDA Data Integrity for Computerized Systems

Time: April 24, 2017 at 9am to April 25, 2017 at 6pm
Location: Mandarin Orchard Singapore
Street: 333 Orchard Road, Singapore 238867
City/Town: Singapore
Website or Map: http://www.globalcompliancepa…
Phone: 1-800-447-9407
Event Type: seminar
Organized By: NetZealous DBA as GlobalCompliancePanel
Latest Activity: Feb 21, 2017

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Event Description


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.

This is a very hands-on class and the attendees will be given take away templates that will enable them to build a complete package to meet Data Integrity Requirements for Computerized Systems

The Seminar:

This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows:

  1. What is Data Integrity and how is it implemented
  2. How to use Risk Based Assessments to reduce work while still achieving Data Integrity and Compliance?
  3. Data Integrity Frequently Asked Questions
  4. Validation Master Plan
  5. Risk Based Assessment
  6. Complete Validation for a System (software development lifecycle)
  7. Automated Test Tools
  8. Infrastructure Requirements

    Venue: Mandarin Orchard Singapore

    Address: 333 Orchard Road, Singapore 238867

    Tel: (65) 6235 7788




    Price: $1,695.00 (Seminar Fee for One Delegate)


    Register for 5 attendees Price: $5085.00 $8,475.00 You Save: $3390.00 (40%)*


    Until March 10, Early Bird Price: $1,695.00 from March 11 to April 22, Regular Price: $1,895.00


    Quick Contact:

    NetZealous DBA as GlobalCompliancePanel


    Phone: 1-800-447-9407

    Fax: 302-288-6884



    Registration Link -

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