Good Laboratory Practice Training Manual
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Good Laboratory Practice Training Manual
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2010-02-02
Good Laboratory Practice Training Manual written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-02-02 with Medical categories.
This manual is designed to be used by the trainee at Special Program for Research and Training in Tropical Diseases and Good Laboratory Practice training workshops. It contains an introduction which highlights the history of the OECD principles of GLP, and the fundamental points. Included is training on the resources required (personnel and facilities); preparation of the protocol and standard operating procedures (SOPs); characterization of the test item (its storage, use, quality control, test system); documentation (reporting, deviations from the protocol, indexing, archiving, retrieval); and quality assurance (validity of results must be ensured through all phases of a study). The material is presented in a clear, lively and informative way. Also included are several practical and interesting workshops on how to prepare, review and improve protocols and standard operating procedures, based on actual case studies. Finally there is a self-assessment questionnaire-so the trainee can recognize how much he/she has learned and what issues need clarification, if any.
Good Laboratory Practice Training Manual
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Author : World Health Organization
language : en
Publisher:
Release Date : 2010
Good Laboratory Practice Training Manual written by World Health Organization and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Medical categories.
This manual is aimed at trainers of good laboratory practice (GLP) and is a companion manual to the GLP training manual for the trainee.
Good Laboratory Practice Training Manual
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Author :
language : en
Publisher:
Release Date : 2001
Good Laboratory Practice Training Manual written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001 with categories.
Good Laboratory Practice Glp Training Manual For The Trainee
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Author :
language : en
Publisher:
Release Date : 2009
Good Laboratory Practice Glp Training Manual For The Trainee written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009 with Communicable diseases categories.
Glp Essentials
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Author : Milton A. Anderson
language : en
Publisher: CRC Press
Release Date : 2002
Glp Essentials written by Milton A. Anderson and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002 with Medical categories.
Concise and easy to follow, this book explains the implementation of Good Laboratory Practices (GLPs). The second edition of a standard reference, GLP Essentials identifies and describes the required elements of managing a scientific study including its planning, performance, reporting, and monitoring. The author includes a brief, informative discussion of the historical development of GLPs and the rationale for establishing these requirements in the rapidly expanding scientific research and regulatory environment. Written especially for readers involved in ensuring the integrity of their scientific documentation, this book is useful for individual and group training programs.
Quality Control Training Manual
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Author : Syed Imtiaz Haider
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Quality Control Training Manual written by Syed Imtiaz Haider and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences
Good Laboratory Practice Regulations
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Author : Sandy Weinberg
language : en
Publisher: CRC Press
Release Date : 2007-01-19
Good Laboratory Practice Regulations written by Sandy Weinberg and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-01-19 with Medical categories.
Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresse
Laboratory Management System General Requirements
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Author : Pawan Bharati Kumar
language : en
Publisher: Discovery Publishing House Pvt Limited
Release Date : 2020-04
Laboratory Management System General Requirements written by Pawan Bharati Kumar and has been published by Discovery Publishing House Pvt Limited this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-04 with Education categories.
The present book updates the subject content on Laboratory Management System; Effective Handling of Lab Instruments and Chemicals, Safety in Microbiology Laboratory, Cultivation of Great Work Habits; Quality Management Systems (QMS) - Requirements (ISO 9001:2015); Environmental Management Systems (EMS) ISO-14001 - Requirements with guidance, Occupational Health and Safety Management Systems (OHSAS-18001): Requirements; Integrated Management System (IMS) Manual; Good Laboratory Practice (GLP) Training Manual and Guidelines; OECD Principles of GLP.
Good Laboratory Practice For Nonclinical Studies
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Author : Graham P. Bunn
language : en
Publisher: CRC Press
Release Date : 2022-12-13
Good Laboratory Practice For Nonclinical Studies written by Graham P. Bunn and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-12-13 with Medical categories.
The GLP regulations have been enacted since 1978 and are currently under a proposed FDA amendment to revise terminology and accommodate other changes relating to advances in technology related to the industry. This book provides a unique opportunity to access interpretation of the 21CFR58 regulatory requirements from leading industry experts with a vast knowledge and expertise in their fields. The approach used takes the regulations, provides interpretations and references to examples and regulatory actions. Data integrity and the use of electronic systems in compliance with 21CFR11 Electronic Records: Electronic Signatures are also discussed. • Unique volume covering FDA inspections of GLP facilities • Provides a detailed interpretation of GLP Regulations • Presents the latest on electronic data management in GLP • Describes GLP and computer systems validation • Can be referenced repeatedly in supporting daily hands on implementation of the CFR requirements
Implementing A Good Laboratory Practice Training Program For Regulatory Personnel
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Author : Julia Solarczyk Donnelly
language : en
Publisher:
Release Date : 2006
Implementing A Good Laboratory Practice Training Program For Regulatory Personnel written by Julia Solarczyk Donnelly and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006 with Laboratories categories.