Author: Philip Carson
Publisher: Royal Society of Chemistry
ISBN: 1847557724
Category : Science
Languages : en
Pages : 657
Book Description
Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.
Good Clinical, Laboratory and Manufacturing Practices
Author: Philip Carson
Publisher: Royal Society of Chemistry
ISBN: 1847557724
Category : Science
Languages : en
Pages : 657
Book Description
Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.
Publisher: Royal Society of Chemistry
ISBN: 1847557724
Category : Science
Languages : en
Pages : 657
Book Description
Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.
Good Clinical, Laboratory and Manufacturing Practices
Author: Phillip A. Carson
Publisher: Royal Society of Chemistry
ISBN: 0854048340
Category : Science
Languages : en
Pages : 657
Book Description
Provides practical advice for the quality assurance professional responsible for monitoring compliance with legal requirements and accepted standards of preclinical safety studies, clinical trials and manufacture of drugs. This book also offers a framework for integrating these standards with other quality management systems.
Publisher: Royal Society of Chemistry
ISBN: 0854048340
Category : Science
Languages : en
Pages : 657
Book Description
Provides practical advice for the quality assurance professional responsible for monitoring compliance with legal requirements and accepted standards of preclinical safety studies, clinical trials and manufacture of drugs. This book also offers a framework for integrating these standards with other quality management systems.
Good Clinical Laboratory Practice (GCLP)
Author: Tim Stiles
Publisher:
ISBN: 9781904610007
Category : Clinical trials
Languages : en
Pages : 18
Book Description
Publisher:
ISBN: 9781904610007
Category : Clinical trials
Languages : en
Pages : 18
Book Description
Good Laboratory Practice for Nonclinical Studies
Author: Graham P. Bunn
Publisher: CRC Press
ISBN: 1000789594
Category : Medical
Languages : en
Pages : 179
Book Description
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
Publisher: CRC Press
ISBN: 1000789594
Category : Medical
Languages : en
Pages : 179
Book Description
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
Good Laboratory Practice Regulations
Author: Sandy Weinberg
Publisher: CRC Press
ISBN: 0849375843
Category : Medical
Languages : en
Pages : 306
Book Description
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
Publisher: CRC Press
ISBN: 0849375843
Category : Medical
Languages : en
Pages : 306
Book Description
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
Good Clinical Laboratory Practice
Author: David Hutchinson
Publisher:
ISBN: 9781908278647
Category : Clinical trials
Languages : en
Pages : 34
Book Description
Publisher:
ISBN: 9781908278647
Category : Clinical trials
Languages : en
Pages : 34
Book Description
Good Laboratory and Clinical Practices
Author: Phillip A. Carson
Publisher: Butterworth-Heinemann
ISBN:
Category : Medical
Languages : en
Pages : 424
Book Description
This book provides practical and detailed advice for the quality assurance professional who is responsible for monitoring compliance with legal requirements and accepted standards and guidelines. This manual is useful for those subject to inspection and audit, such as toxicologists, ecotoxicologists, technicians, analysts, chemists, clinicians, and process managers.
Publisher: Butterworth-Heinemann
ISBN:
Category : Medical
Languages : en
Pages : 424
Book Description
This book provides practical and detailed advice for the quality assurance professional who is responsible for monitoring compliance with legal requirements and accepted standards and guidelines. This manual is useful for those subject to inspection and audit, such as toxicologists, ecotoxicologists, technicians, analysts, chemists, clinicians, and process managers.
The Regulatory Compliance Almanac
Author: Les Schnoll
Publisher: Paton Professional
ISBN: 9781932828191
Category : Law
Languages : en
Pages : 564
Book Description
Publisher: Paton Professional
ISBN: 9781932828191
Category : Law
Languages : en
Pages : 564
Book Description
Good Laboratory and Clinical Practices Techniques for the Quality Assurance
Author: Milton A Anderson
Publisher:
ISBN: 9789994014156
Category :
Languages : en
Pages :
Book Description
Publisher:
ISBN: 9789994014156
Category :
Languages : en
Pages :
Book Description
Good Manufacturing Practices for Pharmaceuticals
Author: Joseph D. Nally
Publisher: CRC Press
ISBN: 1420020935
Category : Medical
Languages : en
Pages : 418
Book Description
With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.
Publisher: CRC Press
ISBN: 1420020935
Category : Medical
Languages : en
Pages : 418
Book Description
With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.