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Laboratory Control System Operations in a GMP Environment, David M. Bliesner


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Цена: 19792.00р.
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При оформлении заказа до: 2025-08-04
Ориентировочная дата поставки: Август-начало Сентября
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Автор: David M. Bliesner
Название:  Laboratory Control System Operations in a GMP Environment
ISBN: 9781119529231
Издательство: Wiley
Классификация:

ISBN-10: 1119529239
Обложка/Формат: Hardcover
Страницы: 352
Вес: 0.67 кг.
Дата издания: 23.07.2020
Серия: Chemistry
Язык: English
Размер: 240 x 165 x 21
Читательская аудитория: Professional & vocational
Ключевые слова: Chemical engineering,Chemistry
Ссылка на Издательство: Link
Рейтинг:
Поставляется из: Англии
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.




Analytical Chemistry in a GMP Environment: A Practical Guide

Автор: James M. Miller
Название: Analytical Chemistry in a GMP Environment: A Practical Guide
ISBN: 0471314315 ISBN-13(EAN): 9780471314318
Издательство: Wiley
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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.

Process Control System Fault Diagnosis - a Bayesian Approach

Автор: Huang
Название: Process Control System Fault Diagnosis - a Bayesian Approach
ISBN: 1118770617 ISBN-13(EAN): 9781118770610
Издательство: Wiley
Рейтинг:
Цена: 16782.00 р.
Наличие на складе: Поставка под заказ.

Описание: Process Control System Fault Diagnosis: A Bayesian Approach Ruben T. Gonzalez, University of Alberta, Canada Fei Qi, Suncor Energy Inc.

Essential Elements for a GMP Analytical Chemistry Department

Автор: Thomas Catalano
Название: Essential Elements for a GMP Analytical Chemistry Department
ISBN: 1489996745 ISBN-13(EAN): 9781489996749
Издательство: Springer
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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.

Quality and GMP Auditing

Автор: Vesper, James L.
Название: Quality and GMP Auditing
ISBN: 0367400901 ISBN-13(EAN): 9780367400903
Издательство: Taylor&Francis
Рейтинг:
Цена: 9798.00 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.

Quality And Gmp Auditing: Clear And Simple

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.

Gmp/iso quality audit manual for healthcare manufacturers and their suppliers, (volume 2 - regulations, standards, and guidelines)

Автор: Steinborn, Leonard
Название: Gmp/iso quality audit manual for healthcare manufacturers and their suppliers, (volume 2 - regulations, standards, and guidelines)
ISBN: 0367393328 ISBN-13(EAN): 9780367393328
Издательство: Taylor&Francis
Рейтинг:
Цена: 9798.00 р.
Наличие на складе: Нет в наличии.

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

Essential Elements for a GMP Analytical Chemistry Department

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.

Aquatic chemistry :

Автор: Lahav, Ori.
Название: Aquatic chemistry :
ISBN: 3110603926 ISBN-13(EAN): 9783110603927
Издательство: Walter de Gruyter
Цена: 10990.00 р.
Наличие на складе: Есть у поставщика Поставка под заказ.

Описание:

This book provides chemical concepts as well as crucial steps for inorganic water and wastewater treatment. Examples and tools help to understand and to guide through industrial and natural water process engineering. Students in chemical and environmental engineering as well as researchers and professionals benefit from this concise and explanatory book.

Hazardous Substances: Risks and Regulations

Автор: Thomas Schupp
Название: Hazardous Substances: Risks and Regulations
ISBN: 3110618052 ISBN-13(EAN): 9783110618051
Издательство: Walter de Gruyter
Цена: 12078.00 р.
Наличие на складе: Есть у поставщика Поставка под заказ.

Описание:

This title presents a detailed overview on the full range of hazard categories and the associated risks of chemicals. It provides a basic introduction into toxicology, ecotoxicology and environmental behavior and enables all who perform precise chemical analysis to handle substances according to their intrinsic properties such as physical-chemical, environmental, ecological and toxicological hazards.

Uncertainty-Aware Integration of Control with Process Operations and Multi-Parametric Programming Under Global Uncertainty

Автор: Charitopoulos Vassilis M.
Название: Uncertainty-Aware Integration of Control with Process Operations and Multi-Parametric Programming Under Global Uncertainty
ISBN: 3030381366 ISBN-13(EAN): 9783030381363
Издательство: Springer
Рейтинг:
Цена: 13974.00 р.
Наличие на складе: Есть у поставщика Поставка под заказ.

Описание: This book introduces models and methodologies that can be employed towards making the Industry 4.0 vision a reality within the process industries, and at the same time investigates the impact of uncertainties in such highly integrated settings.


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