Author: Donald C Singer
Publisher: CRC Press
ISBN: 9780367392468
Category :
Languages : en
Pages : 496
Book Description
Identifying current tools, techniques, and approaches for the evaluation of laboratory operations, this reference reviews the latest regulatory standards and auditing practices to test laboratory safety, quality, and performance.
Laboratory Auditing for Quality and Regulatory Compliance
Author: Donald C Singer
Publisher: CRC Press
ISBN: 9780367392468
Category :
Languages : en
Pages : 496
Book Description
Identifying current tools, techniques, and approaches for the evaluation of laboratory operations, this reference reviews the latest regulatory standards and auditing practices to test laboratory safety, quality, and performance.
Publisher: CRC Press
ISBN: 9780367392468
Category :
Languages : en
Pages : 496
Book Description
Identifying current tools, techniques, and approaches for the evaluation of laboratory operations, this reference reviews the latest regulatory standards and auditing practices to test laboratory safety, quality, and performance.
Drugs and the Pharmaceutical Sciences V.150
Guidelines for Laboratory Quality Auditing
Author: Doanld C. Singer
Publisher: CRC Press
ISBN: 1498710522
Category : Technology & Engineering
Languages : en
Pages : 430
Book Description
This single-source reference provides practical guidance for the quality auditing of a chemical or biological testing laboratory-helping to develop or improve quality control and quality assurance programs in order to meet certification standards or pass external-source audits.
Publisher: CRC Press
ISBN: 1498710522
Category : Technology & Engineering
Languages : en
Pages : 430
Book Description
This single-source reference provides practical guidance for the quality auditing of a chemical or biological testing laboratory-helping to develop or improve quality control and quality assurance programs in order to meet certification standards or pass external-source audits.
Good Laboratory Practice Regulations, Revised and Expanded
Author: Sandy Weinberg
Publisher: CRC Press
ISBN: 0203911083
Category : Medical
Languages : en
Pages : 249
Book Description
Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general g
Publisher: CRC Press
ISBN: 0203911083
Category : Medical
Languages : en
Pages : 249
Book Description
Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general g
A Laboratory Quality Handbook of Best Practices
Author: Donald C. Singer
Publisher: Quality Press
ISBN: 0873891090
Category : Business & Economics
Languages : en
Pages : 401
Book Description
Based on the work of a collection of experts from the laboratory science and quality assurance fields, A Laboratory Quality Handbook of Best Practices and Relevant Regulations provides all of the information needed to run a successful laboratory that is in compliance with all regulations. From sample tracking to accurate documentation, training to methods validation, maintenance to calibration, and out-of-spec responses to preparation for audits, a combination of people, instrumentation and documentation must work in sync for high quality results. This handbook provides information that will help a laboratory achieve high quality results and compliance. Contents: Quality Assurance in the Laboratory, History of Regulation, Training in the Laboratory, Laboratory Documentation and Data, Sample Control and LIM Systems, Methods Validation
Publisher: Quality Press
ISBN: 0873891090
Category : Business & Economics
Languages : en
Pages : 401
Book Description
Based on the work of a collection of experts from the laboratory science and quality assurance fields, A Laboratory Quality Handbook of Best Practices and Relevant Regulations provides all of the information needed to run a successful laboratory that is in compliance with all regulations. From sample tracking to accurate documentation, training to methods validation, maintenance to calibration, and out-of-spec responses to preparation for audits, a combination of people, instrumentation and documentation must work in sync for high quality results. This handbook provides information that will help a laboratory achieve high quality results and compliance. Contents: Quality Assurance in the Laboratory, History of Regulation, Training in the Laboratory, Laboratory Documentation and Data, Sample Control and LIM Systems, Methods Validation
Glp Quality Audit Manual
Author: Milton A. Anderson
Publisher: Informa Healthcare
ISBN: 9781574911060
Category : Business & Economics
Languages : en
Pages : 424
Book Description
Designed to enable readers to plan and execute their own audits, this comprehensive guide presents both discussions and practical applications related to establishing a GLP QA unit and performing effective GLP audits. The first section provides the foundation of information needed for designing and initiating a Good Laboratory Practice quality assurance program. Section II contains ready-to-use audit checklists and regulatory references that are in accordance with the most recent regulations. Section III illustrates with examples the document requirements of the Quality Assurance Unit and provides a clear understanding of its function. Section IV comprises the full texts of the relevant standards and regulations along with the Principles of Good Laboratory Practice.
Publisher: Informa Healthcare
ISBN: 9781574911060
Category : Business & Economics
Languages : en
Pages : 424
Book Description
Designed to enable readers to plan and execute their own audits, this comprehensive guide presents both discussions and practical applications related to establishing a GLP QA unit and performing effective GLP audits. The first section provides the foundation of information needed for designing and initiating a Good Laboratory Practice quality assurance program. Section II contains ready-to-use audit checklists and regulatory references that are in accordance with the most recent regulations. Section III illustrates with examples the document requirements of the Quality Assurance Unit and provides a clear understanding of its function. Section IV comprises the full texts of the relevant standards and regulations along with the Principles of Good Laboratory Practice.
Regulated Bioanalytical Laboratories
Author: Michael Zhou
Publisher: John Wiley & Sons
ISBN: 047092280X
Category : Science
Languages : en
Pages : 564
Book Description
This book provides useful information for bioanalytical / analytical scientists, analysts, quality assurance managers, and all personnel in bioanalytical laboratories through all aspects of bioanalytical technical and regulatory perspectives within bioanalytical operations and processes. Readers learn how to develop and implement strategies for routine, non-routine, and standard bioanalytical methods and on the entire equipment hardware and software qualification process. The book also gives guidelines on qualification of certified standards and in-house reference material as well as on people qualification. Finally, it guides readers through stressless internal and third party laboratory audits and inspections. It takes account to most national and international regulations and quality and accreditation standards, along with corresponding interpretation and inspection guides. The author elaborates on highly comprehensive content, making it easy not only to learn the subject but also to quickly implement the recommendations.
Publisher: John Wiley & Sons
ISBN: 047092280X
Category : Science
Languages : en
Pages : 564
Book Description
This book provides useful information for bioanalytical / analytical scientists, analysts, quality assurance managers, and all personnel in bioanalytical laboratories through all aspects of bioanalytical technical and regulatory perspectives within bioanalytical operations and processes. Readers learn how to develop and implement strategies for routine, non-routine, and standard bioanalytical methods and on the entire equipment hardware and software qualification process. The book also gives guidelines on qualification of certified standards and in-house reference material as well as on people qualification. Finally, it guides readers through stressless internal and third party laboratory audits and inspections. It takes account to most national and international regulations and quality and accreditation standards, along with corresponding interpretation and inspection guides. The author elaborates on highly comprehensive content, making it easy not only to learn the subject but also to quickly implement the recommendations.
Good Laboratory Practice Regulations, Third Edition, Revised and Expanded
Author: Sandy Weinberg
Publisher: CRC Press
ISBN: 0824745647
Category : Medical
Languages : en
Pages : 256
Book Description
Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general guidelines for the management of efficient and effective research environment. A guide to the current standards and requirements of good laboratory management, the book examines essential theoretical principles for anticipating new and emerging interpretations of GLP in a variety of laboratory settings.
Publisher: CRC Press
ISBN: 0824745647
Category : Medical
Languages : en
Pages : 256
Book Description
Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general guidelines for the management of efficient and effective research environment. A guide to the current standards and requirements of good laboratory management, the book examines essential theoretical principles for anticipating new and emerging interpretations of GLP in a variety of laboratory settings.
Establishing A CGMP Laboratory Audit System
Author: David M. Bliesner
Publisher: John Wiley & Sons
ISBN: 047178477X
Category : Science
Languages : en
Pages : 295
Book Description
The first systematic, hands-on auditing guide for today's pharmaceutical laboratories In today's litigious environment, pharmaceutical laboratories are subject to ever stricter operational guidelines as mandated by the FDA, and must be able to establish and demonstrate sustainable operational practices that ensure compliance with the current good manufacturing practice (CGMP) regulations. David Bliesner's Establishing a CGMP Laboratory Audit System: A Practical Guide is designed to provide laboratory supervisors and personnel with a step-by-step, hands-on audit system that they can rely on to ensure their facility remains compliant with all current and future requirements. Focusing on a "team approach," the author uses detailed flowcharts, checklists, and descriptions of the auditing process to help readers develop a new audit system or upgrade their current system in order to: * Improve current compliance * Demonstrate sustainable compliance * Produce data for federal inspections * Avoid regulatory action Enhanced with detailed checklists and a wealth of practical and flexible auditing tools on CD-ROM, this book provides an ideal resource for new and future laboratory personnel, and an excellent means for keeping existing industry practitioners up to date on the nuances of operating a consistently compliant pharmaceutical laboratory.
Publisher: John Wiley & Sons
ISBN: 047178477X
Category : Science
Languages : en
Pages : 295
Book Description
The first systematic, hands-on auditing guide for today's pharmaceutical laboratories In today's litigious environment, pharmaceutical laboratories are subject to ever stricter operational guidelines as mandated by the FDA, and must be able to establish and demonstrate sustainable operational practices that ensure compliance with the current good manufacturing practice (CGMP) regulations. David Bliesner's Establishing a CGMP Laboratory Audit System: A Practical Guide is designed to provide laboratory supervisors and personnel with a step-by-step, hands-on audit system that they can rely on to ensure their facility remains compliant with all current and future requirements. Focusing on a "team approach," the author uses detailed flowcharts, checklists, and descriptions of the auditing process to help readers develop a new audit system or upgrade their current system in order to: * Improve current compliance * Demonstrate sustainable compliance * Produce data for federal inspections * Avoid regulatory action Enhanced with detailed checklists and a wealth of practical and flexible auditing tools on CD-ROM, this book provides an ideal resource for new and future laboratory personnel, and an excellent means for keeping existing industry practitioners up to date on the nuances of operating a consistently compliant pharmaceutical laboratory.
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