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Posts Tagged ‘Quality by Design’

Avoiding Moisture Variability in Fluidized Bed Dryer Operations

Posted in Life Sciences, Project Services on Thursday, June 21st, 2012. 2 comments so far
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In an earlier post, Trends in Process Analytical Technology and Quality by Design, I highlight a point made in the video, “…PAT methods around product moisture, which projected a $2 million annual savings in improved product quality.” The methodology used for the project to achieve these results was highlighted in a post, Using Operational Excellence […]

Trends in Process Analytical Technology and Quality by Design

Posted in Life Sciences on Tuesday, June 5th, 2012. 2 comments so far
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At the recent conference for pharmaceutical and biotech manufacturers, Interphex 2012, Pharmaceutical Manufacturing magazine Editor in Chief Agnes Shanley discussed trends in the industry’s use of process analytical technology (PAT) and quality by design (QbD) with Emerson’s Director of Life Sciences Industry Consulting, Chris Amstutz. Their discussion was captured in this 4:48 YouTube video, Emerson […]

ASTM E2500-Early, Targeted Testing Leads to Faster Implementations

Posted in Life Sciences, Regulatory Compliance on Wednesday, January 25th, 2012. No comments yet
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Last week, I highlighted Emerson’s Heather Schwalje thoughts on Continuous Process Verification per U.S. Food & Drug Administration (FDA) guidelines. In a comment, Pharmaceutical Manufacturing magazine senior editor, Paul Thomas, highlighted a great article, A Practical Roadmap to Pharmaceutical Process Validation for Pharmaceutical and Biotech manufacturers. I saw another great analysis piece by Heather on […]

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, 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 FDA-Partnering with Industry conference. Melissa describes the process of organizational change as it applies to the Process […]