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Implementing Process Analytical Technology and Continuous Process Verification

Posted in Data Management, Life Sciences on Tuesday, August 12th, 2014. One comment so far
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In the 4:42 video, Life Science Drug Process Development and Manufacturing, Emerson’s Gary Mitchell highlights the changes occurring for pharmaceutical and biotech manufacturers. Gary opens noting how these manufacturers are challenged to respond to new methods for drug process development and manufacturing. The U.S. Food and Drug Administration (FDA) is driving manufacturers in the Life […]

Implementing Quality by Design

Posted in Life Sciences on Thursday, February 20th, 2014. 2 comments so far
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Many manufacturers in the Life Sciences industry are challenged to respond to a new paradigm for process development and manufacturing. The FDA’s cGMP for the 21st Century initiative is driving the industry to change its development and manufacturing to be based on process understanding and a risk based approach. This new paradigm uses terminology such […]