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 Technology (PAT) to the pharmaceutical industry and create a venue for dialogue between the PAT users.”
My presentation addressed the Use of Data Analytics in Pharmaceutical Manufacturing. In particular I focused on how on-line data analytics can be used to bridge the gap that often exists between the measurement of quality parameters and process control. I included several examples to show how this technology can be effectively applied in both chemical and biological batch processes. Also, results of a field trail at the Lubrizol, Rouen plant were presented to demonstrate the operational benefits that some plants have realized through the use of on-line data analytics. To learn more on this topic, you can download and view the presentation I gave at this conference.
One of the highlights of the conference was a presentation by Melissa B. Herkt, President and COO of the PlantWeb Solutions Group of Emerson Process Management. The topic of her presentation was Where is the “Burning Ambition” for PAT/QbD? If you are working to promote PAT/QbD within your organization as a means of improving product quality and manufacturing efficiency, then I would encourage you to view the video tape of her presentation.