Guidelines for Laboratory Quality Auditing

Guidelines for Laboratory Quality Auditing
Author: Doanld C. Singer
Publisher: CRC Press
Total Pages: 430
Release: 2014-07-22
Genre: Technology & Engineering
ISBN: 1498710522

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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.

Guidelines for Laboratory Quality Auditing

Guidelines for Laboratory Quality Auditing
Author: Donald C. Singer
Publisher: Asq Press
Total Pages: 411
Release: 1993-05-01
Genre: Business & Economics
ISBN: 9780873891738

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P 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. /P

A Laboratory Quality Handbook of Best Practices

A Laboratory Quality Handbook of Best Practices
Author: Donald C. Singer
Publisher: Quality Press
Total Pages: 401
Release: 2001-09-25
Genre: Business & Economics
ISBN: 0873891090

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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

Laboratory Auditing for Quality and Regulatory Compliance

Laboratory Auditing for Quality and Regulatory Compliance
Author: Donald C Singer
Publisher: CRC Press
Total Pages: 496
Release: 2019-08-30
Genre:
ISBN: 9780367392468

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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.

Establishing A CGMP Laboratory Audit System

Establishing A CGMP Laboratory Audit System
Author: David M. Bliesner
Publisher: John Wiley & Sons
Total Pages: 295
Release: 2006-04-28
Genre: Science
ISBN: 047178477X

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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.

Guidelines for Laboratory Quality Managers

Guidelines for Laboratory Quality Managers
Author: Saverio Mannino
Publisher: Springer Nature
Total Pages: 170
Release: 2022-11-22
Genre: Technology & Engineering
ISBN: 3031117247

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This useful and extensive set of guidelines is designed to assist food control laboratories in gaining accreditation from an internationally recognized external body, providing all of the necessary information and practices in an easy-to-read, step-by-step fashion. Authored by an experienced consultant for laboratory accreditation in many different countries, with this text food control lab owners now have all of the up-to-date information they need to gain accreditation in a single source. Guidelines for Laboratory Quality Managers covers the essentials for quality management in the food control laboratory, from testing processes to current quality management systems. The ISO standards for accreditation are extensively explored, including managerial requirements, organizational aspects, complaint handling procedures, internal audits, and sampling. An entire section is dedicated to the implementation of managerial and technical requirements from quality control to program monitoring and evaluation. Analysis selection, preparation, and validation is covered extensively, and an entire section is dedicated to basic statistics from data presentation to distribution. Each section comes with helpful tips for lab managers plus definitions and terms. Comprehensive, easy-to-use and up-to-date, Guidelines for Laboratory Quality Managers is the guide for accreditation for food control laboratories.

The Laboratory Quality Assurance System

The Laboratory Quality Assurance System
Author: Thomas A. Ratliff
Publisher: John Wiley & Sons
Total Pages: 246
Release: 2005-03-11
Genre: Technology & Engineering
ISBN: 0471721662

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Both the 17025:1999 standard and especially ANSI/ISO/ASQ,9001-2000 standard require that a laboratory document its procedures for obtaining reliable results. The Laboratory Quality Assurance Manual details to the user how to a prepare a new laboratory quality assurance manual, which will be appropriate to use as a procedures manual for a particular laboratory, a sales tool to attract potential customers, a document that can be to answer regulatory questions, and ultimately a tool to become a registered ISO 9001/2000 Lab and gain related certifications based on the standard. The Laboratory Quality Assurance Manual: -Incoporates changes to ANSI/ISO/ASQ 9001-2000 pertaining to laboratories. -Provides blank forms used in preparing a quality manual. -Provides information on the interrelationship of ANSI/ISO 17025:1999 and ANSI/ISO/ASQ 9001-2000.

Guidelines for Laboratory Quality Managers

Guidelines for Laboratory Quality Managers
Author: Saverio Mannino
Publisher:
Total Pages: 0
Release: 2023
Genre:
ISBN: 9783031117251

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This useful and extensive set of guidelines is designed to assist food control laboratories in gainingaccreditation from an internationally recognized external body, providing all of the necessary information and practices in an easy-to-read, step-by-step fashion. Authored by an experienced consultant for laboratory accreditation in many different countries, with this text food control lab owners now have all of the up-to-date information they need to gain accreditation in a single source. Guidelines for Laboratory Quality Managers covers the essentials for quality management in the food control laboratory, from testing processes to current quality management systems. The ISO standards for accreditation are extensively explored, including managerial requirements,organizational aspects, complaint handling procedures, internal audits, and sampling. An entire section is dedicated to the implementation of managerial and technical requirements from quality control to program monitoring and evaluation. Analysis selection, preparation, and validation is covered extensively, and an entire section is dedicated to basic statistics from data presentation todistribution. Each section comes with helpful tips for lab managers plus definitions and terms. Comprehensive, easy-to-use and up-to-date, Guidelines for Laboratory Quality Managers isthe guide for accreditation for food control laboratories. .