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Risk Management Applications In Pharmaceutical And Biopharmaceutical Manufacturing
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Risk Management Applications In Pharmaceutical And Biopharmaceutical Manufacturing

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:NT$ 5584 元
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905026
若需訂購本書,請電洽客服 02-25006600[分機130、131]。
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Officers from pharmaceutical companies and quality and compliance consultants suggest some approaches and measures that both companies and regulatory agencies can take to provide more thorough risk management in the manufacture of pharmaceutical and biopharmaceutical products. Among the topics are risk management tools, statistical topics and analysis in risk assessment, process development and clinical product manufacturing, points to consider for commissioning and qualifying manufacturing facilities and equipment, aseptic processing, and risk-based change control. Annotation c2013 Book News, Inc., Portland, OR (booknews.com)

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A. HAMID MOLLAH, PhD, is the Head of Quality Engineering and Validation at XOMA. He has also held positions at Genentech and Baxter. He is a RAPS Certified Regulatory Affairs Professional and ASQ Certified Quality Engineer.

Dr. MIKE LONG, has two decades of experience leading product, process development, and validation efforts on a wide range of pharmaceutical, medical device, and combination products. He is a frequent speaker and writer on topics such as risk management, quality systems, quality by design, and process validation.

HAROLD S. BASEMAN, MBA, Principal and Chief Operating Officer, ValSource LLC, has more than thirty years of experience in pharmaceutical operations, validation, and regulatory compliance. He has held positions in executive management and technical operations at several manufacturing and consulting firms.

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優惠價:90 5026
若需訂購本書,請電洽客服 02-25006600[分機130、131]。

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