The Clinical Audit Handbook

The Clinical Audit Handbook
Author: Clare Morrell
Publisher: Bailliere Tindall Limited
Total Pages: 216
Release: 1999
Genre: Medical
ISBN: 9780702024184

By reading and assimilating the information in this handbook professionals, involved in clinical audits and practice development, will be able to design, plan and implement an audit project for patient care in line with up-to-date evidence.

The ASQ Certified Medical Device Auditor Handbook

The ASQ Certified Medical Device Auditor Handbook
Author: Scott A Laman
Publisher: Quality Press
Total Pages: 372
Release: 2021-02-05
Genre: Medical
ISBN: 1953079970

The ASQ Certified Medical Device Auditor Handbook (formerly The Biomedical Quality Auditor Handbook) was developed by the ASQ Medical Device Division (formerly Biomedical Division) in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the medical device community. It principally serves as a resource to candidates preparing for the Certified Medical Device Auditor (CMDA) certification exam. The fourth edition of this handbook has been reorganized to align with the 2020 certification exam Body of Knowledge (BoK) and reference list. The combination of this handbook with other reference materials can provide a well-rounded background in medical device auditing. Updates to this edition include: • A discussion of data privacy, data integrity principles, and the Medical Device Single Audit Program (MDSAP) • Current information about federal and international regulations • New content regarding human factors and usability engineering, general safety and performance requirements, labeling, validation, risk management, and cybersecurity considerations • A thorough explanation of quality tools and techniques

National Clinical Audits

National Clinical Audits
Author: David Pruce
Publisher: Royal College of Physicians
Total Pages: 68
Release: 2000
Genre: Medical audit
ISBN: 9781860161292

The Audit Handbook

The Audit Handbook
Author: I. K. Crombie
Publisher: Wiley
Total Pages: 242
Release: 1993-06-08
Genre: Medical
ISBN: 9780471937661

Auditing enables health care practitioners to determine the best ways of delivering high quality service. This text discusses the major issues and gives descriptions of the important practical problems and how to overcome them. Also provides case studies and a review of relevant literature.

The ASQ Certified Quality Auditor Handbook

The ASQ Certified Quality Auditor Handbook
Author: Lance B. Coleman
Publisher: Quality Press
Total Pages: 417
Release: 2020-02-01
Genre: Business & Economics
ISBN: 1951058100

The value of the ASQ Certified Quality Auditor Handbook, Fifth Edition, is clear. It is designed to help new auditors gain an understanding of the field and prepare for the ASQ CQA exam. In addition, experienced auditors can refer to it as a helpful reference; audit managers and quality managers can rely on it for guiding their auditing programs; and trainers and educators can use it for teaching fundamentals. This in-depth overview of quality auditing represents auditing practices for internal and external applications. It provides practical guidance for both system and process auditors as well. Many current topics have been expanded to reflect changes in auditing practices since 2012, with guidance from the recent 2017 update of ISO 19011. In addition, readers will find example audit situations, stories, and review comments to enhance their understanding of the field. Topics covered include the common elements of all types of system and process audits (quality, environmental, safety, and health): Auditing fundamentals, including types of quality audits, purpose and scope of auditing, terms and definitions, roles and responsibilities of participants, and professional conduct The audit process, from preparation and planning, to performance and reporting, to follow-up and closure Auditor competencies, including resource management, conflict resolution, communication, interviewing, and team dynamics Audit program management and business applications, including staffing, training and development, program evaluation, organizational risk management, and best practices Quality tools and techniques, including problem-solving tools, process improvement techniques, basic statistics, verification, and validation "This book is an encyclopedia of all major bodies of information a new or experienced quality auditor would need. It covers both the qualitative and the quantitative, which is a strength. I can't think of a quality auditor that would not find this work helpful." Kim H. Pries, CRE, CQE, CSQE, CSSBB, CMQ/OE, CQA "This handbook will be helpful to those who are new to auditing or require more in-depth knowledge of the implementation of an audit program. Boxed examples or scenarios provide some of the practical challenges encountered during auditing." Govind Ramu, ASQ Fellow, Co-Author ASQ SSGB Handbook, Author ASQ CSSYB Handbook Lance B. Coleman, Sr. has over 25 years of leadership experience in the areas of quality engineering, Lean implementation, quality, and risk management in the Medical Device, Aerospace, and other regulated industries. He has presented, trained, and consulted throughout the United States and abroad. Lance is currently a Director of Quality for IDEX Health and Science, LLC, in Oak Harbor, Washington.

Environmental, Health, and Safety Auditing Handbook

Environmental, Health, and Safety Auditing Handbook
Author: Lee Harrison
Publisher: McGraw-Hill Professional Publishing
Total Pages: 680
Release: 1995
Genre: Medical
ISBN:

This text is designed to answer the new awareness and concern about the environment and health and safety issues, by corporations operating in the USA and internationally, since the environmental audit became a routine part of corporate business. As with any other type of audit, the process includes a careful review of all aspects of the process and the plant (past and present) that could cause health, safety or environmental problems.

Clinical Trials Audit Preparation

Clinical Trials Audit Preparation
Author: Vera Mihajlovic-Madzarevic
Publisher: John Wiley & Sons
Total Pages: 186
Release: 2010-09-29
Genre: Medical
ISBN: 0470920882

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