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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Author | : James E. Sayre |
Publisher | : Interpharm CRC |
Total Pages | : 250 |
Release | : 1990 |
Genre | : Clinical trials |
ISBN | : 9780935184181 |
Author | : Vera Mihajlovic-Madzarevic |
Publisher | : Wiley |
Total Pages | : 246 |
Release | : 2010-06-01 |
Genre | : Medical |
ISBN | : 9780470248850 |
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
Author | : James P. Russell |
Publisher | : |
Total Pages | : 0 |
Release | : 2000 |
Genre | : Auditing |
ISBN | : 9780873894609 |
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.
Author | : |
Publisher | : |
Total Pages | : |
Release | : 1994 |
Genre | : |
ISBN | : 9789991943312 |
Author | : Dennis R. Arter |
Publisher | : Quality Press |
Total Pages | : 156 |
Release | : 2002-11-06 |
Genre | : Business & Economics |
ISBN | : 087389572X |
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.
Author | : International Atomic Energy Agency |
Publisher | : Bernan Press(PA) |
Total Pages | : 164 |
Release | : 1984 |
Genre | : Business & Economics |
ISBN | : |
Author | : Leonard Steinborn |
Publisher | : CRC Press |
Total Pages | : 633 |
Release | : 2019-04-23 |
Genre | : Medical |
ISBN | : 0429525826 |
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
Author | : Jackelyn Stewert |
Publisher | : |
Total Pages | : 158 |
Release | : 2021-06-30 |
Genre | : |
ISBN | : |
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
Author | : University Grants Committee (Hong Kong, China). Quality Assurance Council |
Publisher | : |
Total Pages | : 80 |
Release | : 2008 |
Genre | : Education, Higher |
ISBN | : |
Author | : |
Publisher | : Institute of Internal Auditors, Incorporated |
Total Pages | : 252 |
Release | : 2002 |
Genre | : Business & Economics |
ISBN | : |