GCP Quality Audit Manual

GCP Quality Audit Manual
Author: James E. Sayre
Publisher: Interpharm CRC
Total Pages: 250
Release: 1990
Genre: Clinical trials
ISBN: 9780935184181

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Clinical Trials Audit Preparation

Clinical Trials Audit Preparation
Author: Vera Mihajlovic-Madzarevic
Publisher: Wiley
Total Pages: 246
Release: 2010-06-01
Genre: Medical
ISBN: 9780470248850

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A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals. Among the topics discussed: Good Clinical Practices and therapeutic product development in clinical research The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee The roles and responsibilities of the clinical trial investigator The inspection preparation The Audit Report and the Form 483 Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development

The Quality Audit Handbook

The Quality Audit Handbook
Author: James P. Russell
Publisher:
Total Pages: 0
Release: 2000
Genre: Auditing
ISBN: 9780873894609

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This edition includes coverage on ethics, the correlation of auditing to business performance, and the expansion into areas not covered by the Certified Quality Auditor Body of Knowledge. It has been designed to be used as a resource for nearly every aspect of the auditing function.

Glp Quality Audit Manual

Glp Quality Audit Manual
Author:
Publisher:
Total Pages:
Release: 1994
Genre:
ISBN: 9789991943312

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Quality Audits for Improved Performance

Quality Audits for Improved Performance
Author: Dennis R. Arter
Publisher: Quality Press
Total Pages: 156
Release: 2002-11-06
Genre: Business & Economics
ISBN: 087389572X

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Perfect for anyone charged with implementing a quality audit program or those performing the audit, this book is an ideal reference on the established techniques of quality auditing. This third edition serves as a guide to learning and applying the basics of quality auditing, and expands on the basic auditing principles by showing how the quality audit can be used to improve business performance. This new edition includes: - An expanded background and history of quality auditing - A general model for auditing any quality management system - Added information on process audits and the system-process-product relationship - Auditor competencies and qualifications - An explanation of audit reports and the role of the auditor after the report - New material on remedial and corrective action - Example audit procedures and a glossary of auditing terms Author Dennis Arter addresses both internal and supplier auditing as it relates to any quality management system, including ISO 9001, GMP, automotive, and others. He provides supportive examples and checklists throughout the text to help make this book the best single-source guide on the subject. Quality practitioners, registrars, and those preparing for the ASQ Certified Quality Auditor (CQA) exam will find it to be an invaluable reference.

Manual on Quality Assurance Programme Auditing

Manual on Quality Assurance Programme Auditing
Author: International Atomic Energy Agency
Publisher: Bernan Press(PA)
Total Pages: 164
Release: 1984
Genre: Business & Economics
ISBN:

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GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 1 - With Checklists and Software Package)

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 1 - With Checklists and Software Package)
Author: Leonard Steinborn
Publisher: CRC Press
Total Pages: 633
Release: 2019-04-23
Genre: Medical
ISBN: 0429525826

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Volume 1 of this two-part package provides a complete set of checklists for internal and contract device and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed material, electronic component, and general supplies. It also includes a simulated QSIT audit, and a new-product market launch. All of these

The Quality Audit Process Manual

The Quality Audit Process Manual
Author: Jackelyn Stewert
Publisher:
Total Pages: 158
Release: 2021-06-30
Genre:
ISBN:

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As well as being an integral part of compliance and regulatory requirements, audits are essential for assessing the success of processes, products, and systems-whether existing or newly implemented. They are also a vital tool for verifying objective evidence of processes and providing evidence for the reduction and elimination of any problem areas. To ensure maximum benefit for an organization, quality auditing should highlight examples of good practice, rather than simply identifying non-conformance, process issues, and corrective actions. This will allow other departments to share information and adjust their working practices, delivering continuous improvement as a result. This book is perfect for anyone charged with implementing a quality audit program or those performing the audit, this book is an ideal reference on the established techniques of quality auditing. This third edition serves as a guide to learning and applying the basics of quality auditing, and expands on the basic auditing principles by showing how the quality audit can be used to improve business performance. This new edition includes: - An expanded background and history of quality auditing - A general model for auditing any quality management system - Added information on process audits and the system-process-product relationship - Auditor competencies and qualifications - An explanation of audit reports and the role of the auditor after the report - New material on remedial and corrective action - Example audit procedures and a glossary of auditing terms

Quality Assurance Council

Quality Assurance Council
Author: University Grants Committee (Hong Kong, China). Quality Assurance Council
Publisher:
Total Pages: 80
Release: 2008
Genre: Education, Higher
ISBN:

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Quality Assessment Manual

Quality Assessment Manual
Author:
Publisher: Institute of Internal Auditors, Incorporated
Total Pages: 252
Release: 2002
Genre: Business & Economics
ISBN:

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