Guide to Cell Therapy GxP

Written By Joaquim Vives
Guide to Cell Therapy GxP
  • Publsiher : Academic Press
  • Release : 24 July 2015
  • ISBN : 0128031166
  • Pages : 266 pages
  • Rating : /5 from reviews
GET THIS BOOKGuide to Cell Therapy GxP


Download or read book entitled Guide to Cell Therapy GxP by author: Joaquim Vives which was release on 24 July 2015 and published by Academic Press with total page 266 pages . This book available in PDF, EPUB and Kindle Format. Guide to Cell Therapy GxP is a practical guide to the implementation of quality assurance systems for the successful performance of all cell-based clinical trials. The book covers all information that needs to be included in investigational medicinal product dossier (IMPD), the launching point for any clinical investigation, and beyond. Guide to Cell Therapy GxP bridges a knowledge gap with the inclusion of examples of design of GLP-compliant preclinical studies; design of bioprocesses for autologous/allogeneic therapies; and instruction on how to implement GLP/GMP standards in centers accredited with other quality assurance standards. Guide to Cell Therapy GxP is an essential resource for scientists and researchers in hospitals, transfusion centers, tissue banks, and other research institutes who may not be familiar with the good scientific practice regulations that were originally designed for product development in corporate environments. This book is also a thorough resource for PhD students, Post-docs, Principal Investigators, Quality Assurance Units, and Government Inspectors who want to learn more about how quality standards are implemented in public institutions developing cell-based products. Easy access to important information on current regulations, state-of-the-art techniques, and recent advances otherwise scattered on various funding websites, within conference proceedings, or maintained in local knowledge Features protocols, techniques for trouble-shooting common problems, and an explanation of the advantages and limitations of a technique in generating conclusive data Includes practical examples of successful implementation of quality standards

Guide to Cell Therapy GxP

Guide to Cell Therapy GxP
  • Author : Joaquim Vives,Gloria Carmona
  • Publisher : Academic Press
  • Release Date : 2015-07-24
  • Total pages : 266
  • ISBN : 0128031166
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Summary : Guide to Cell Therapy GxP is a practical guide to the implementation of quality assurance systems for the successful performance of all cell-based clinical trials. The book covers all information that needs to be included in investigational medicinal product dossier (IMPD), the launching point for any clinical investigation, and beyond. ...

Guide to Cell Therapy GxP Quality Standards in the Development of Cell Based Medicines in Non pharmaceutical Environments

Guide to Cell Therapy GxP  Quality Standards in the Development of Cell Based Medicines in Non pharmaceutical Environments
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2021-07-24
  • Total pages : 212
  • ISBN : 0128031166
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Summary : Read online Guide to Cell Therapy GxP Quality Standards in the Development of Cell Based Medicines in Non pharmaceutical Environments written by , published by which was released on . Download full Guide to Cell Therapy GxP Quality Standards in the Development of Cell Based Medicines in Non pharmaceutical Environments Books now! ...

Cell Therapy

Cell Therapy
  • Author : Adrian Gee
  • Publisher : Springer
  • Release Date : 2014-12-03
  • Total pages : 256
  • ISBN : 0128031166
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Summary : Cell Therapy: cGMP Facilities and Manufacturing is the source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring. This in-depth book also includes detailed reviews of quality, the framework of ...

EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP
  • Author : Orlando Lopez
  • Publisher : CRC Press
  • Release Date : 2015-04-06
  • Total pages : 379
  • ISBN : 0128031166
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Summary : Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems.The purpose of Annex 11 is...

The Role of the Study Director in Nonclinical Studies

The Role of the Study Director in Nonclinical Studies
  • Author : William J. Brock,Barbara Mounho,Lijie Fu
  • Publisher : John Wiley & Sons
  • Release Date : 2014-06-03
  • Total pages : 545
  • ISBN : 0128031166
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Summary : A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the ...

Ensuring the Integrity of Electronic Health Records

Ensuring the Integrity of Electronic Health Records
  • Author : Orlando Lopez
  • Publisher : CRC Press
  • Release Date : 2020-12-22
  • Total pages : 320
  • ISBN : 0128031166
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Summary : Data integrity is a critical aspect to the design, implementation, and usage of any system which stores, processes, or retrieves data. The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended and, upon later retrieval, ensure the data is the same as ...

Data Integrity in Pharmaceutical and Medical Devices Regulation Operations

Data Integrity in Pharmaceutical and Medical Devices Regulation Operations
  • Author : Orlando Lopez
  • Publisher : CRC Press
  • Release Date : 2016-11-03
  • Total pages : 372
  • ISBN : 0128031166
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Summary : Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years’ experience in regulated industries in various ...

American Biotechnology Laboratory

American Biotechnology Laboratory
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2008
  • Total pages : 212
  • ISBN : 0128031166
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Summary : Read online American Biotechnology Laboratory written by , published by which was released on 2008. Download full American Biotechnology Laboratory Books now! Available in PDF, ePub and Kindle....

Manual of Veterinary Transfusion Medicine and Blood Banking

Manual of Veterinary Transfusion Medicine and Blood Banking
  • Author : Kenichiro Yagi,Marie Holowaychuk
  • Publisher : John Wiley & Sons
  • Release Date : 2016-09-06
  • Total pages : 408
  • ISBN : 0128031166
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Summary : Using a practical approach, the Manual of Veterinary Transfusion Medicine and Blood Banking provides veterinary practitioners with evidence-based guidelines to refer to at the clinical practice level. Provides evidence-based information on transfusion medicine and blood banking practices Presents sections on recipient screening, donor selection, blood collection and storage, and how ...

Case Studies in Primary Care

Case Studies in Primary Care
  • Author : Jeffrey A. Eaton,Joyce D. Cappiello
  • Publisher : Mosby Incorporated
  • Release Date : 1998
  • Total pages : 346
  • ISBN : 0128031166
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Summary : "Real world" case studies for 44 of the most commonly encountered situations in primary care: includes scheduled appointments, follow-up evaluations, and phone calls; features all age groups and a variety of cultures; provides a mix of client detail and background information, with a few surprises thrown in ... just like a "normal ...

B A S I C

B A S I C
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1965
  • Total pages : 212
  • ISBN : 0128031166
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Summary : Read online B A S I C written by , published by which was released on 1965. Download full B A S I C Books now! Available in PDF, ePub and Kindle....

Benn s Media

Benn s Media
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2004
  • Total pages : 212
  • ISBN : 0128031166
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Summary : Read online Benn s Media written by , published by which was released on 2004. Download full Benn s Media Books now! Available in PDF, ePub and Kindle....