guide to cell therapy gxp

Guide To Cell Therapy GxP
Author: Joaquim Vives
Publisher: Academic Press
Release Date: 2015-07-24
Pages: 266
ISBN:
Available Language: English, Spanish, And French
EBOOK SYNOPSIS:

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  Quality Standards In The Development Of Cell Based Medicines In Non Pharmaceutical Environments
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Available Language: English, Spanish, And French
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Exam Prep For  Guide To Cell Therapy Gxp  Quality Standards
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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
Pages: 379
ISBN:
Available Language: English, Spanish, And French
EBOOK SYNOPSIS:

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
Author: William J. Brock
Publisher: John Wiley & Sons
Release Date: 2014-06-03
Pages: 545
ISBN:
Available Language: English, Spanish, And French
EBOOK SYNOPSIS:

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 roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry

Ensuring The Integrity Of Electronic Health Records
Author: Orlando Lopez
Publisher: CRC Press
Release Date: 2020-12-22
Pages: 320
ISBN:
Available Language: English, Spanish, And French
EBOOK SYNOPSIS:

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 it was when originally recorded. Any alternation to the data is then traced to the person who made the modification. The integrity of data in a patient’s electronic health record is critical to ensuring the safety of the patient. This book is relevant to production systems and quality control systems associated with the manufacture of pharmaceuticals and medical device products and updates the practical information to enable better understanding of the controls applicable to e-records. The book highlights the e-records suitability implementation and associated risk-assessed controls, and e-records handling. The book also provides updated regulatory standards from global regulatory organizations such as MHRA, Medicines and Healthcare Products Regulatory Agency (UK); FDA, Food and Drug Administration (US); National Medical Products Association (China); TGA, Therapeutic Goods Administration (Australia); SIMGP, Russia State Institute of Medicines and Good Practices; and the World Health Organization, to name a few.

American Biotechnology Laboratory
Author:
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Release Date: 2008
Pages:
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Available Language: English, Spanish, And French
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Genetic Engineering News
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Release Date: 2006
Pages:
ISBN:
Available Language: English, Spanish, And French
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