Tag Archive: PAT

Dec
06

Roundtable Presentation – Life Science Industry Forum

The Food and Drug Administration issued the guideline “Guidance for Industry, PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance” in September, 2004. The objective of this guidance was to “describe a regulatory framework (Process Analytical Technology, PAT) that will encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and …

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Nov
04

Batch Process Analytics – update –

Over the last three years the DeltaV future architecture team has worked closely with Lubrizol to develop and install a beta version of Emerson’s on-line batch analytics. At Emerson Exchange 2010 the Lubrizol Corp. represented by Robert Wojewodka, Technology Manager, Process Improvement Team Leader, accepted the 2010 PlantWeb Excellence Award for exceptional application of PlantWeb …

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Oct
28

Use of Data Analytics in Pharmaceutical Manufacturing

Earlier this year I had the pleasure of speaking at a conference on FDA and PAT for Pharma Manufacturing, FDA-Partnering with Industry. This 2-day conference was co-sponsored by the FDA and the University Of Rhode Island College Of Pharmacy. The primary object of this conference was to “Disseminate current and accurate information on Process Analytical …

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