Using their considerable knowledge and experience of pharmaceutical manufacturing, the authors take you through the various elements involved in a process: man, machine, materials, method and environment. They discuss quality control and assurance, tools for quality improvements and ways of designing the process to effectively manage outgoing quality. They believe that for processes to run successfully, all employees must be problem-solvers. With the right process design, every problem can be broken down into solvable elements. Pharmaceutical Process Design and Management shows you how to do just that.…mehr
Using their considerable knowledge and experience of pharmaceutical manufacturing, the authors take you through the various elements involved in a process: man, machine, materials, method and environment. They discuss quality control and assurance, tools for quality improvements and ways of designing the process to effectively manage outgoing quality. They believe that for processes to run successfully, all employees must be problem-solvers. With the right process design, every problem can be broken down into solvable elements. Pharmaceutical Process Design and Management shows you how to do just that.Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.
Kate McCormick has extensive experience in pharmaceutical manufacturing, having worked with companies and regulators worldwide. She has published several textbooks and articles, edited GMP Review from 2004 to 2011 and is a former education advisor for ISPE. McCormick has qualifications in biochemistry, microbiology and business studies. Wylie McVay has extensive operations support experience in pharmaceutical quality control, quality assurance and post-approval regulatory affairs. McVay is a review board member of the Journal of Validation Technology and GxP Compliance magazines. He is certified in Quality and Regulatory and holds a Master of Science in Quality Assurance and Regulatory Affairs.
Inhaltsangabe
Introduction Part I Evolution of Process Design and Management: Why process management is important Artisan heritage. Part II Five Process Elements: Man: the mind of the process Machine: the voice of the process Method: the techniques of process control Materials: the life-blood of the process Environment. Part III Effective Pharmaceutical Process Design and Management: Changing the way we think Cause and effect: getting to the root cause Corrective action and preventive action: fixing the inevitable oops Process-driven quality systems Statistics and decision boundaries: data certainty Problem-solving tools and techniques Reducing the risk: the new paradigm Customers Process integrated accounting Appendix List of references Index.
Introduction Part I Evolution of Process Design and Management: Why process management is important Artisan heritage. Part II Five Process Elements: Man: the mind of the process Machine: the voice of the process Method: the techniques of process control Materials: the life-blood of the process Environment. Part III Effective Pharmaceutical Process Design and Management: Changing the way we think Cause and effect: getting to the root cause Corrective action and preventive action: fixing the inevitable oops Process-driven quality systems Statistics and decision boundaries: data certainty Problem-solving tools and techniques Reducing the risk: the new paradigm Customers Process integrated accounting Appendix List of references Index.
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