The Management of Chemical Process Development in the Pharmaceutical Industry by Derek Walker pdf free download

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The Management of Chemical Process Development in the Pharmaceutical Industry by Derek Walker pdf free download

The Management of Chemical Process Development in the Pharmaceutical Industry by Derek Walker pdf free download

Several very useful books on the subject of chemical process development have been published.1 These have been written largely from the point of view of the bench chemist or chemical engineer. Emphasis in this collection of books is on the work needed to ensure that practical chemical reactions are created for scale-up, that the chemistry is understood, that the theory and mechanics needed to engineer scaleup are addressed, and that Safety, Environment and Food and Drug Administration requirements are met. This book is about the management of the people, organization, and the main disciplines which have to be to be integrated to create and develop a chemical process to meet all the needs. Management recognizes that people are the most important assets in their organization and that inspiring leadership provides the best driving force for success. The major requirements for such leadership are reviewed. In today’s pharmaceutical industry, leaders need to be visionaries with the ability to motivate their scientist and engineer co-workers to express themselves, to take risks, and to harness sound judgment in fusing together the many components that form a chemical process. Personal examples are used throughout the book to illustrate this. A few of the frameworks through which people are recognized and rewarded for their achievements are described. People recognition and rewards are undertaken in partnership with the company Human Resources function. Organization of the work of scientists and engineers and how this is integrated with other disciplines to provide the foundations for success in achieving defined missions is outlined. It is recognized that organizations need to be flexible and be prepared to change to meet the unexpected and also the different needs of different missions. The main “outside” disciplines influencing the progress of chemical process development in the pharmaceutical industry are process safety, environmental considerations, and FDA regulatory affairs. The basic principles governing these disciplines and the major activities needed to meet the requirements in these areas are summarized. Beyond the regulatory disciplines, the vital importance of patenting and defending intellectual property is also emphasized. An outline of the chemical engineer’s role in chemical process development is given with particular emphasis on chemical plant equipment requirements for the major unit operations.

The Management of Chemical Process Development in the Pharmaceutical Industry by Derek Walker pdf free download

 

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