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2021 - Data Integrity: FDA/EU Requirements and Implementation
Date2021-01-21 - 2021-01-22
Deadline2021-01-11
VenueVirtual Seminar, USA - United States 
KeywordsGuideline on data integrity; Fda data integrity checklist; Fda data integrity training
Topics/Call fo Papers
Understand what data integrity is and why it is so important for patient safety
Recognise that there are many causes of data integrity breaches
Know the current regulatory expectations
Appreciate the difference between static and dynamic records, and be able to apply acceptable strategies for the retention of both types of record
Be able to categorise and validate GxP computerised systems according to GAMP 5
Understand the importance of training and quality culture in avoiding regulatory enforcement action
Learn how to respond to data integrity observations in inspection reports
Learn how to prevent, detect and remedy data integrity problems
Recognise that there are many causes of data integrity breaches
Know the current regulatory expectations
Appreciate the difference between static and dynamic records, and be able to apply acceptable strategies for the retention of both types of record
Be able to categorise and validate GxP computerised systems according to GAMP 5
Understand the importance of training and quality culture in avoiding regulatory enforcement action
Learn how to respond to data integrity observations in inspection reports
Learn how to prevent, detect and remedy data integrity problems
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Last modified: 2020-12-18 15:38:38