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Volume 1: Comprehensive Guide to Pharmaceutical Regulatory Affairs: Principles and Practices - Couverture souple
Synopsis
Comprehensive Guide to Pharmaceutical Regulatory Affairs is an essential resource for anyone involved in the pharmaceutical industry, particularly those working in regulatory affairs. This book provides a thorough understanding of the principles and practices that ensure the safety, efficacy, and quality of pharmaceutical products.
It begins with Good Regulatory Practices, providing a strong foundation in the basic principles of regulatory affairs. Subsequent chapters delve into Good Laboratory Practices, Good Automated Laboratory Practices, and Good Distribution Practices, each offering detailed insights into maintaining high standards across different stages of pharmaceutical production and distribution.
The section on Quality Management Systems explores the implementation of effective quality assurance mechanisms, ensuring that all pharmaceutical products meet stringent quality standards. Detailed chapters on Documentation and Regulatory Writing, Dossier Preparation and Submission, and Audits offer practical guidance on the critical documentation processes and audit procedures required for regulatory approval and ongoing compliance.
The book also addresses the complexities of Inspections and Product Life Cycle Management, providing comprehensive guidance on maintaining compliance throughout the product lifecycle. A comprehensive List of Abbreviations and Acronyms and a detailed Bibliography serve as valuable reference tools, enhancing the utility of this guide.
Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.
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Volume 1: Comprehensive Guide to Pharmaceutical Regulatory Affairs: Principles and Practices
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Volume 1
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PAP. Etat : New. New Book. Shipped from UK. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000. N° de réf. du vendeur L0-9798895199244
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Volume 1
impression à la demandeVendeur : PBShop.store UK, Fairford, GLOS, Royaume-Uni
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PAP. Etat : New. New Book. Delivered from our UK warehouse in 4 to 14 business days. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000. N° de réf. du vendeur L0-9798895199244
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Volume 1: Comprehensive Guide to Pharmaceutical Regulatory Affairs: Principles and Practices
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Volume 1 : Comprehensive Guide to Pharmaceutical Regulatory Affairs: Principles and Practices
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Taschenbuch. Etat : Neu. Neuware - Comprehensive Guide to Pharmaceutical Regulatory Affairs is an essential resource for anyone involved in the pharmaceutical industry, particularly those working in regulatory affairs. This book provides a thorough understanding of the principles and practices that ensure the safety, efficacy, and quality of pharmaceutical products. N° de réf. du vendeur 9798895199244
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Volume 1 (Paperback)
Vendeur : CitiRetail, Stevenage, Royaume-Uni
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Paperback. Etat : new. Paperback. Comprehensive Guide to Pharmaceutical Regulatory Affairs is an essential resource for anyone involved in the pharmaceutical industry, particularly those working in regulatory affairs. This book provides a thorough understanding of the principles and practices that ensure the safety, efficacy, and quality of pharmaceutical products. It begins with Good Regulatory Practices, providing a strong foundation in the basic principles of regulatory affairs. Subsequent chapters delve into Good Laboratory Practices, Good Automated Laboratory Practices, and Good Distribution Practices, each offering detailed insights into maintaining high standards across different stages of pharmaceutical production and distribution.The section on Quality Management Systems explores the implementation of effective quality assurance mechanisms, ensuring that all pharmaceutical products meet stringent quality standards. Detailed chapters on Documentation and Regulatory Writing, Dossier Preparation and Submission, and Audits offer practical guidance on the critical documentation processes and audit procedures required for regulatory approval and ongoing compliance.The book also addresses the complexities of Inspections and Product Life Cycle Management, providing comprehensive guidance on maintaining compliance throughout the product lifecycle. A comprehensive List of Abbreviations and Acronyms and a detailed Bibliography serve as valuable reference tools, enhancing the utility of this guide. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability. N° de réf. du vendeur 9798895199244
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