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Quality provides comprehensive application of regulatory guidelines and quality concepts and methodologies related to pharmaceutical manufacturing. It is an excellent resource for practitioners, those pursuing pharmaceutical related certifications, and for students trying to learn more about pharmaceutical manufacturing. The book not only provides applied descriptions of the guidelines and concepts, but it also includes short case studies that demonstrate applications as well as questions and problems at the end of the chapters that will help provide practice for the reader to apply the concepts.In this book the authors share their extensive experience of 30+ years of practical experience in the industry and in process improvement applications combined with a detailed understanding of the needs of the industry education system. The book provides real-life examples from industry and guidelines for practical application of tools that can be referenced by operators, engineers, and management.The book is fully revised, updated and expanded with 25% new content in areas such as QbD, Lean, Six Sigma, Basic data analysis, CAPA tools, and Pharma 4.0. Fully revised, updated and 25% expanded new edition Features new topics such as QbD, Lean, Six Sigma, Basic data analysis, CAPA tools, and Pharma 4.0 Includes End of Chapter Summaries and End of Chapter Question and/or Problems Presents real-life case studies from industry Provides detailed steps and examples for applying the guidelines and quality tools Written in an accessible style making the content easy to understand and apply
