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Compliance Hot Topics Series

Feb 1, 2012

Presented By Waters

FDA Issues New Guidance on LC/GC Data; Clarifies Part 11
This podcast discusses recent FDA guidance concerning chromatographic data and its impact including the criticality of adopting electronic data review practices.
Dana Yurach
Senior Manager, Global Compliance Services
Waters Corporation

211.68(a) What is it? Why is it important? How does it apply to my Chromatography Data System?
The number of US FDA inspectional observations citing 21CFR 211.68(a) has increased by over thirty percent in recent years. This webcast discusses why this may be and frames the requirements of this part in the context of computers within a Chromatography Data System. Sponsored by Waters Corporation
Dana Yurach
Senior Manager, Global Compliance Services
Systems Laboratory
Waters Corporation

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