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| In this audio interview, Don Singer, a Malcolm Baldrige National Quality Award Examiner and ASQ national director, certified specialist microbiologist and Six Sigma Green Belt discusses pharma's progress along the road to continuous quality improvement. Could a pharma company win the Baldrige Prize one day? Perhaps, but as Singer says, the journey is far more important than the destination. Benchmarking and connecting with experts from other industries, and adopting their best practices, is critical. |
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| Aegis Analytical's Justin Neway goes into further detail on the necessity of process development and manufcturing being on the same team in this audio presentation. |
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| Pfizer's global business supply head Michael Arnold witnessed it all, and shares his thoughts on China, FDA, Cost Reduction, and the "Mother Ship." |
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| Quality by Design is already transforming drug manufacturing—an unstoppable force, really—and smart manufacturers know where to find it: in their own plants and in the ideas of vendor partners and industry colleagues. QbD optimists Arvindh Balakrishnan of Oracle and Russ Somma of SommaTech LLC say the future is now. |
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| Design of Experiments software is being perfected for chromatography, dissolution, and tablet manufacturing, and as QbD goes “mainstream,” even pharmaceutical executives are shopping around for good software like this, says Graham Shelver of S-Matrix Corp. Shelver cautions that many software vendors will jump on the QbD bandwagon with products that have not proven themselves in pharmaceutical environments. |
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