Labcompliance On-line Audio Seminar
Analytical laboratory equipment and computer systems are amongst key targets of FDA inspections. They are considered high risk systems because they can have a high impact on product quality. Validation can be a challenge because laboratory instruments become more and more complex and automated. In the past there was no specific guidance on how to combine analytical instrument qualification with system validation. This has changed. The USP Chapter <1058> on "Analytical Instrument Qualification" is focused on equipment qualification and the new GAMP/ISPE Good Practice Guide "Risk based Approach to GxP Compliant Laboratory Computerized System" is more focused on automated systems. Both USP and GAMP/ISPE are important FDA references but unfortunately the concepts are different. So the question is: how to integrate?
(Courtesy of labcompliance.com)
For more information, please visit: http://www.labcompliance.com/seminars/audio/321/default.aspx
12 September 2013 - North America: ET 11 a.m. CT 10 a.m. PT 8 a.m., Europe: CET 5 p.m. (Paris/Berlin)
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