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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: 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 are 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 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: Introduction / Background Data Integrity 21 CFR 11 & Annex 11 Risk Assessment & Requirements Design Verification & Testing Special Topics Change Control & SOPsThe Problem:
The Seminar:
Who Should Attend:
Agenda:
Day One
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Lecture 2:
Lecture 3:
Lecture 4:
Day Two
Lecture 1:
Lecture 2:
Lecture 3:
Lecture 4: