Tag Archive: QbD


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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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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