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2020 - Data Integrity: FDA/EU Requirements and Implementation

Date2020-03-26 - 2020-03-27


VenueSan Diego, CA, USA - United States USA - United States

KeywordsData integrity workshop; Gxp regulations; Fda part 11


Topics/Call fo Papers

Attendees will:
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

Last modified: 2020-01-14 04:04:13