Kate McCormick, D. Wylie McVay Jr

Pharmaceutical Process Design and Management (eBook, ePUB)

• Format: ePub

Produktbeschreibung

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.

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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 288
• Erscheinungstermin: 22. April 2016
• Englisch
• ISBN-13: 9781317081395
• Artikelnr.: 49352298

Autorenporträt

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.