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Posts Tagged ‘Food and Drug Administration’

Successfully Implementing Process Analytical Technology

Posted in Life Sciences on Tuesday, October 31st, 2017. No comments yet
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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, Manufacturing, and Quality Assurance. While conceptually understandable, it has taken time for PAT to be put into […]

FDA Guidance for Data Integrity and Compliance

Posted in Life Sciences on Thursday, April 28th, 2016. No comments yet
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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 to note from this document. The FDA has provided this […]

US FDA Quality Metrics Guidelines Update

Posted in Life Sciences, Operations Management on Thursday, September 3rd, 2015. No comments yet
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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 data they want to verify quality. However, the FDA’s push is leaving […]

Continuous Process Verification per FDA Process Validation Guidance

Posted in Life Sciences, Operations Management on Thursday, January 19th, 2012. 10 comments so far
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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. Heather shared key elements from this FDA process validation guidance document and how […]

Organizational Change and Process Analytical Technology and Quality by Design

Posted in Life Sciences, Operations Management on Tuesday, June 8th, 2010. No comments yet
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On Pharmaceutical Manufacturing magazine’s web site, 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 FDA-Partnering with Industry conference. Melissa describes the process of organizational change as it applies to the Process […]