It's been well more than a decade since the U.S. Food & Drug Administration (FDA) announced a Process Analytical Technology (PAT) approach for pharmaceutical manufacturers in their Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development,...
Author: Michalle Adkins In April 2016, the FDA issued Data Integrity and Compliance With CGMP Guidance for Industry. This is on the heels of a lot of related 483s, warning letters, and more severe actions with respect to this issue. There are some interesting things...
Author: Eric Kuebler Since the Continued Process Verification (CPV) guidance in 2011, the U.S. Food and Drug Administration (FDA) has been talking quality and verifying process state of control. Now the FDA is getting around to defining what that looks like and what...
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 industry team....
On Pharmaceutical Manufacturing magazine's web site, PharmaManufacturing.com is an 8-minute video presentation given by Emerson's Melissa Herkt. She gave the presentation, Excellence by Design: Melissa Herkt on The Case for PAT and QbD at the May 11-12 2010...
In an earlier post I mentioned how Emerson's Shenling Yang had taken an assignment in Shanghai, China. She's bringing her expertise in operations management and the Syncade software gained while executing projects as a member of the Life Sciences industry team....
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