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JUL 19, 2017 7:00 AM PDT

Data Integrity and the FDA Guidance

Speaker

Abstract

DATE: July 19, 2017
TIME: 7:00am PT, 10:00am ET, 4:00pm CET

According to a recent report, 79% of FDA 483 Warning Letters issued in 2016 cited data integrity. In their guidance on data integrity and compliance with CGMP, the FDA issued their ALCOA definition of data integrity. This seminar will discuss ALCOA using cleanroom environmental monitoring data collection in the pharmaceutical industry as an example.


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JUL 19, 2017 7:00 AM PDT

Data Integrity and the FDA Guidance



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