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Continuous Process Verification per FDA Process Validation Guidance
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Jim Cahill
19 Jan 2012
Life Sciences
21 CFR 211
Process validation
CGMP
manufacturing execution system
Process Analytical Technology
Operations Management
FDA
pharmaceutical
electronic batch record
biotech
Food and Drug Administration
deviation management system
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Continuous Process Verification per FDA Process Validation Guidance
It was just about a year ago that the U.S. Food and Drug Administration published their Guidance for Industry – Process Validation: General Principles and Practices. I caught up with Emerson’s Heather Schwalje, a senior consultant on the Life Sciences...
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