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This book is intended to be primarily a supplemental text that can be used to integrate the use of computer packages into introductory business statistics and quantitative methods courses, demonstrating how computer packages can be used to solve statistical and operational research problems.
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This biannual offers detailed coverage of the regulations, requirements, and techniques for the validation of processes and systems used in regulated international industries. It addresses significant requirements for pharmaceutical, medical device, and biologic companies as well as environmental laboratories. It examines Good Manufacturing Principles (GMPs), Good Clinical Practices (GCPs), Good Laboratory Practices (GLPs), Good Automated Library Practices (GALPs), and others, and elucidates up-to-the-minute industry changes and international concerns.
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"Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."
Whenever a question of public policy is addressed, heated arguments ensue. Liberals tout one solution, conservatives another, and still others appear who are neither liberal nor conservative but have their own desired solution. In such a heated political atmosphere, legislators and policy makers need to creatively balance competing factions and wants. This book looks at the practical application of creativity in a broad set of policy areas. The chapters take note of diverse topics like merit treatment, technology, vouchers, and budgeting, while also offering theoretical studies of the concept of creativity and its potential in the coming years. Concluding the book is a bibliography of books about creativity.