Posts Tagged ‘CGMP’

Designing and Building Pharmaceutical and Biotech Smart Factories

Posted in Life Sciences, Operations Management on Wednesday, February 7th, 2018. No comments yet
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Pharmaceutical and biotech manufacturers seek to improve both project and operational performance through implementation of smart factory technology. The smart factory fits right into the S95 enterprise automation model and provides out-of-box manufacturing functionality representing the best practice in the industry and complying with the regulation such as cGMP. The smart factory technology connects the […]

Pharmaceutical and Biotech Manufacturing Data Integrity

Posted in Life Sciences on Thursday, November 10th, 2016. No comments yet
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The integrity of the data behind the production of pharmaceutical products is paramount. In recent years, the U.S. Food & Drug Administration (FDA) has increasingly observed data integrity related Current Good Manufacturing Practices (CGMP) violations during CGMP inspections. At the recent Emerson Exchange conference, Emerson’s Michalle Adkins co-moderated the Life Sciences Industry Forum session with […]

Pharmaceutical and Biotech Automation Knowledge Exchange

Posted in Emerson Exchange, Event, Life Sciences on Thursday, October 13th, 2016. No comments yet
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The pharmaceutical and biopharmaceutical industries have been interpreting recent FDA draft guidance—Data Integrity and Compliance With CGMP Guidance—and exploring new areas such as continuous manufacturing. The Emerson Life Sciences team has a full program of forums, workshops and short courses available for manufacturers in the Life Sciences industries at to October 24-28 Emerson Exchange conference […]

What Do You Do for a Living?

Posted in Life Sciences on Monday, August 4th, 2014. One comment so far
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Author: Michalle Adkins I often get asked, “So, what do you do for a living?” Boy is that a loaded question. When I say that I manage a group of Life Sciences Industry Consultants for Emerson—that really does not help to answer the question. Hmmm, how do I describe all of this in a few […]

Optimizing Formulation, Fill and Finish Manufacturing Facilities

Posted in Life Sciences on Thursday, May 22nd, 2014. No comments yet
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Pharmaceutical and biotech manufacturing processes are complex and require well integrated and documented flows of information from upfront forecast demand and customer orders through the production process to inventory receipt and order fulfillment. The components from the enterprise resource planning (ERP) software to the measurement, final control elements, and control systems on the production floor […]