Senior Marketing Manager, Beckman Coulter
BIOGRAPHY
JUL 19, 2017 7:00 AM PDT
Data Integrity and the FDA Guidance
Presented at:
Beckman Coulter Life Sciences Virtual Trade Show
Speaker
Event Date & Time
DATE: July 19, 2017
TIME: 7:00am PT, 10:00am ET, 4:00pm CET
Abstract
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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Data Integrity and the FDA Guidance
Presented at:
Beckman Coulter Life Sciences Virtual Trade Show
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