Tag Archive | "PAT"

PAT, QbD and Process Validation – The Enablers of Pharmaceutical Quality

This presentation delivered by Vibhaker Shah, Ph.D., FDA Senior Policy Advisor, is a great reference resource on the merits of QbD, PAT and their links to the fairly new Process Validation guidance.

Click to view slides

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QbD-Based RTR: A Systems Engineering Approach

by Jose Menezes, 4TUNE Engineering

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Tracing NIR’s Trajectory for Bioprocess Monitoring

By Paul Thomas, Senior Editor

One of the many good talks at the recent MKS Umetrics user meeting in Chicago was that of Roland Bienert, Senior Scientist for PAT and Sensors & Chemometrics at Sartorius Stedim Biotech. Bienert spoke about various new applications of NIR for bioprocessing, and I followed up with him via email to find out more about the work that he and colleagues in Sartorius’ PAT Unit are doing. This unit, Bienert says, is involved in numerous projects that are part of an internal global PAT program initiated several years ago.

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No More Tire Kicking: Chris Amstutz Shares Views on PAT’s Expansion

At the recent Interphex 2012 show in New York City, Agnes Shanley caught up with Chris Amstutz, Director of Life Science Industry Consulting at Emerson Process Management. In the video below, Amstutz provides a brief look at the recent progression of PAT and QbD in the drug industry.

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Can QbD Get Its Definitions Straight?

By Emil W. Ciurczak, Contributing Editor

I have been following a number of conversations on LinkedIn that are driving me to imbibe large amounts of adult beverages. The number of people who disagree on what various terms mean is astounding. For example, we all think we know what PAT means, no? Apparently, no.

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LinkedIn LookIn: Advice, Jabs, Jobs, and More

Every so often we like to browse through pharma industry LinkedIn groups to see what’s being said about QbD, PAT, and other Quality-related topics. What follows is a summary of some recent intriguing threads. (Note: Many of these groups require membership–simply ping the group manager to join.)

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