Автор: Vesper James L Название: Quality And Gmp Auditing: Clear And Simple ISBN: 1574910558 ISBN-13(EAN): 9781574910551 Издательство: Taylor&Francis Рейтинг: Цена: 27562.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: More than just a checklist of audit questions, this guidebook contains proven methods and techniques for performing effective audits. Completely covering the four key competencies essential for successful GMP audits, the book explores the rationale behind using audits as a quality tool and explains the audit cycle broken into five distinct phases. To focus the power of auditing on a particular situation, several different types of audits are presented, as are more than a dozen audit approaches with general questions to answer and specific items to examine. These tools help readers prepare checklists and standards so audits become more effective, consistent, and standardized.
Автор: James M. Miller Название: Analytical Chemistry in a GMP Environment: A Practical Guide ISBN: 0471314315 ISBN-13(EAN): 9780471314318 Издательство: Wiley Рейтинг: Цена: 32464.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: How to hone your analytical skills and obtain high-quality data in the era of GMP requirements With increased regulatory pressures on the pharmaceutical industry, there is a growing need for capable analysts who can ensure appropriate scientific practices in laboratories and manufacturing sites worldwide.
Название: Food Quality, Safety and Technology ISBN: 3709116392 ISBN-13(EAN): 9783709116395 Издательство: Springer Рейтинг: Цена: 23508.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
The present book collects selected contributions from researchers working in the field of food science, and participating at the second spring school for "Food Quality, Safety and Technology," which was held in Botucatu (S o Paulo, Brazil), from September 24th to 27th, 2012, at the Botucatu Campus of the Universidade Estadual Paulista "Julio Mesquita Filho" (UNESP). The goal of the conference was to provide a scientific forum covering large areas of agronomy, nutrition, food science and technology, veterinary and other areas related to food technology development. Teachers, professionals, graduate and post-graduate students in Food Science; Food and Agriculture Engineering; Veterinary, Science and Food Technology and related areas were addressed by providing an exchange of knowledge and technologies. The initiative aimed to establish uniform, globally recognized scientific principles on food safety and quality, which could be consistently applied to industry and production sectors and stakeholders, taking into account that effective food control systems are essential to protecting the health and safety of domestic consumers, to guaranteeing the safety and quality of foods entering international trade, and to ensuring that imported foods conform to national requirements.
Автор: Center for Chemical Process Safety (CCPS, CCPS (Ce Название: Guidelines for Auditing Process Safety Management Systems ISBN: 0470282355 ISBN-13(EAN): 9780470282359 Издательство: Wiley Рейтинг: Цена: 24386.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book discusses the fundamental skills, techniques, and tools of auditing, and the characteristics of a good process safety management system. A variety of approaches are given so the reader can select the best methodology for a given audit.
Описание: Volume 2 of this set contains the full text of the FDA regulations, EC and IPEC guidelines, and ISO/BSI standards referenced in the checklists furnished in Volume I
Автор: Thomas Catalano Название: Essential Elements for a GMP Analytical Chemistry Department ISBN: 1461476410 ISBN-13(EAN): 9781461476412 Издательство: Springer Рейтинг: Цена: 23508.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book outlines planning and implementation of a Good Manufacturing Processes (GMP) analytical program, structured to build an environment and culture that encourages and rewards the sharing of ideas, skills and abilities among department personnel.
Автор: Thomas Catalano Название: Essential Elements for a GMP Analytical Chemistry Department ISBN: 1489996745 ISBN-13(EAN): 9781489996749 Издательство: Springer Рейтинг: Цена: 22201.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book outlines planning and implementation of a Good Manufacturing Processes (GMP) analytical program, structured to build an environment and culture that encourages and rewards the sharing of ideas, skills and abilities among department personnel.
Автор: David M. Bliesner Название: Laboratory Control System Operations in a GMP Environment ISBN: 1119529239 ISBN-13(EAN): 9781119529231 Издательство: Wiley Рейтинг: Цена: 19792.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Develop an understanding of FDA and global regulatory agency requirements for Laboratory Control System (LCS) operations
In Laboratory Control System Operations in a GMP Environment, readers are given the guidance they need to implement a CGMP compliant Laboratory Control System (LCS) that fits within Global Regulatory guidelines. Using the Quality Systems Approach, regulatory agencies like the FDA and the European Medicine Agency have developed a scheme of systems for auditing pharmaceutical manufacturing facilities which includes evaluating the LCS. In this guide, readers learn the fundamental rules for operating a CGMP compliant Laboratory Control System.
Designed to help leaders meet regulatory standards and operate more efficiently, the text includes chapters that cover Laboratory Equipment Qualification and Calibration, Laboratory Facilities, Method Validation and Method Transfer, Laboratory Computer Systems, Laboratory Investigations as well as Data Governance and Data Integrity. The text also includes chapters related to Laboratory Managerial and Administrative Systems, Laboratory Documentation Practices and Standard Operating Procedures and General Laboratory Compliance Practices. Additionally, a chapter outlining Stability Program operations is included in the text.
In addition to these topics, it includes LCS information and tools such as:
● End of chapter templates, checklists, and LCS guidance to help you follow the required standards
● Electronic versions of each tool so users can use them outside of the text
● An In-depth understanding of what is required by the FDA and other globally significant regulatory authorities for GMP compliant systems
For quality assurance professionals working within the pharmaceutical or biopharma industries, this text provides the insight and tools necessary to implement government-defined regulations.
Описание: Good Manufacturing Practice (GMP) refers to advice and guidance put in place to outline the aspects of production and testing that can impact the quality and safety of a product.
Автор: Singer, Donald C. , Stefan, Raluca-Ioana , van S Название: Laboratory Auditing for Quality and Regulatory Compliance ISBN: 0367392461 ISBN-13(EAN): 9780367392468 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Identifying current tools, techniques, and approaches for the evaluation of laboratory operations, this reference reviews the latest regulatory standards and auditing practices to test laboratory safety, quality, and performance.
Автор: N. Chesworth Название: Food Hygiene Auditing ISBN: 1461380545 ISBN-13(EAN): 9781461380542 Издательство: Springer Рейтинг: Цена: 13060.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The radical press of the Victorian era fostered daring literary experiments that helped shape mainstream literature. This book adds significantly to the study of Victorian literary culture by exploring the interplay between canonical social problem novels and journalism and fiction appearing in the periodical press associated with working-class protest.
Описание: "A spirited and absorbing history of emancipation, oppression, and rebellion in the British empire."--C. Vann Woodward. "Holt greatly extends and deepens our understanding of the emancipation experience when, for just over a century, the people of Jamaica struggled to achieve their own vision of freedom and autonomy against powerful conservative forces."--David Barry Gaspar.
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