The Biomedical Quality Auditor Handbook, Third Edition

The Biomedical Quality Auditor Handbook, Third Edition
Author: Heather Crawford
Publisher: Quality Press
Total Pages: 271
Release: 2017-09-08
Genre: Business & Economics
ISBN: 0873899628

The Biomedical Quality Auditor Handbook was developed by the ASQ Biomedical Division in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the biomedical community. This third edition correlates to the 2013 exam Body of Knowledge (BoK) and reference list for ASQ’s Certified Biomedical Auditor program. It includes updates and corrections to errors and omissions in the second edition. Most notably it has been re-organized to align more closely with the BoK.

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

The Biomedical Quality Auditor Handbook

The Biomedical Quality Auditor Handbook
Author: Bruce Haggar
Publisher: Asq Press
Total Pages: 250
Release: 2003-01
Genre: Medical
ISBN: 9780873895767

This new handbook is an excellent resource to support the body of knowledge for the Quality Auditor-Biomedical Certification. it serves as a reference to the application of quality auditor principles to the biomedical industry including coverage of medical devices. Content focuses on the understanding of domestic and international concepts and principles of biomedical quality auditing and includes related regulations, directives, standards, and guidance. Preview a sample chapter from this book along with the full table of contents by clicking here. You will need Adobe Acrobat to view this pdf file.

The Certified Six Sigma Green Belt Handbook, Second Edition

The Certified Six Sigma Green Belt Handbook, Second Edition
Author: Roderick A. Munro
Publisher: Quality Press
Total Pages: 693
Release: 2015-05-13
Genre: Business & Economics
ISBN: 0873898915

This reference manual is designed to help those interested in passing the ASQ's certification exam for Six Sigma Green Belts and others who want a handy reference to the appropriate materials needed to conduct successful Green Belt projects. It is a reference handbook on running projects for those who are already knowledgeable about process improvement and variation reduction. The primary layout of the handbook follows the ASQ Body of Knowledge (BoK) for the Certified Six Sigma Green Belt (CSSGB) updated in 2015. The authors were involved with the first edition handbook, and have utilized first edition user comments, numerous Six Sigma practitioners, and their own personal knowledge gained through helping others prepare for exams to bring together a handbook that they hope will be very beneficial to anyone seeking to pass the ASQ or other Green Belt exams. In addition to the primary text, the authors have added a number of new appendixes, an expanded acronym list, new practice exam questions, and other additional materials

The ASQ Certified Quality Auditor Handbook

The ASQ Certified Quality Auditor Handbook
Author: Lance B. Coleman
Publisher: Quality Press
Total Pages: 324
Release: 2020-02-01
Genre: Business & Economics
ISBN: 1951058119

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.

Design Controls for the Medical Device Industry

Design Controls for the Medical Device Industry
Author: Marie Teixeira
Publisher: CRC Press
Total Pages: 258
Release: 2002-09-20
Genre: Medical
ISBN: 9780203909386

This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilize

The Oxford Handbook of Music Psychology

The Oxford Handbook of Music Psychology
Author: Susan Hallam
Publisher: Oxford University Press
Total Pages: 985
Release: 2016-01-14
Genre: Psychology
ISBN: 0191034452

The second edition of The Oxford Handbook of Music Psychology updates the original landmark text and provides a comprehensive review of the latest developments in this fast-growing area of research. Covering both experimental and theoretical perspectives, each of the 11 sections is edited by an internationally recognised authority in the area. The first ten parts present chapters that focus on specific areas of music psychology: the origins and functions of music; music perception, responses to music; music and the brain; musical development; learning musical skills; musical performance; composition and improvisation; the role of music in everyday life; and music therapy. In each part authors critically review the literature, highlight current issues and explore possibilities for the future. The final part examines how, in recent years, the study of music psychology has broadened to include a range of other disciplines. It considers the way that research has developed in relation to technological advances, and points the direction for further development in the field. With contributions from internationally recognised experts across 55 chapters, it is an essential resource for students and researchers in psychology and musicology.

Handbook of Investigation and Effective CAPA Systems

Handbook of Investigation and Effective CAPA Systems
Author: Jose (Pepe) Rodriguez-Perez
Publisher: Quality Press
Total Pages: 152
Release: 2022-02-15
Genre: Business & Economics
ISBN: 1636940129

Worldwide regulatory agencies perform many inspections annually, and all too often investigation and CAPA system violations are at the top of the list of infractions. Life-sciences regulated companies (not only FDA-regulated ones) must ensure their investigation and CAPA systems look beyond the ‘usual suspects' to identify other quality issues in order to minimize risks (including safe ones) and reduce costs. Enhancements to this third edition include: A new section linking the investigation and CAPA programs with the overall quality culture of the company Fully updated, current versions of regulations including U.S. FDA, EU, ISO 9001, and ISO 13485 Updated inspectional observations from the U.S. FDA and U.K. MHRA A revised investigation and CAPA processes chapter, which has an improved barrier analysis section, including detailed flowcharts describing the barrier analysis process New charts and information related to the investigation of human errors; the human factor section includes information about training and competence A new chapter devoted to analytical laboratory investigations, including a section covering the invalidation of testing results Updated forms and examples of the different elements of the investigation and CAPA plan, including new case studies; a revised diagnostic tool used for investigating human error Jose(Pepe) Rodrguez-Perez, PhD, is president of Business Excellence Consulting, Inc., (BEC), a Puerto Rico-based, consulting, training, and remediation firm that focuses on the areas of regulatory compliance, FDA-regulatory training, and risk management. He is a biologist with a doctoral degree in biology from the University of Granada (Spain). Over his career, he has served as an educator, a technical services manager, and as a science advisor to the FDA.

The ASQ Certified Six Sigma Yellow Belt Handbook

The ASQ Certified Six Sigma Yellow Belt Handbook
Author: Govindarajan Ramu
Publisher: Quality Press
Total Pages: 249
Release: 2022-06-30
Genre: Business & Economics
ISBN: 1952236207

This handbook is a helpful guide to Six Sigma process improvement and variation reduction. Individuals studying to pass the ASQ Certified Six Sigma Yellow Belt (CSSYB) exam will find this comprehensive text invaluable for preparation, and it is also a handy reference for those already working in the field. The handbook offers a comprehensive understanding of the Body of Knowledge (BoK), which will allow readers to support real Six Sigma projects in their current or future roles. This handbook, updated to reflect the 2022 BoK, includes: - A detailed explanation of each section of the CSSYB BoK - Essay-type questions in each chapter to test reading comprehension - Numerous appendices, a comprehensive list of abbreviations, and a glossary of useful terms - Online contents, including practice exam questions - Source lists, which include webinars, tools and templates, and helpful publications

Statistical Process Control for the FDA-Regulated Industry

Statistical Process Control for the FDA-Regulated Industry
Author: Manuel E. Pena-Rodriguez
Publisher: Quality Press
Total Pages: 205
Release: 2013-04-11
Genre: Business & Economics
ISBN: 0873898524

The focus of this book is to understand and apply the different SPC tools in a company regulated by the Food and Drug Administration (FDA): those that manufacture pharmaceutical products, biologics, medical devices, food, cosmetics, and so on. The book is not intended to provide an intensive course in statistics; instead, it is intended to provide a how-to guide about the application of the diverse array of statistical tools available to analyze and improve the processes in an organization regulated by FDA. This book is aimed at engineers, scientists, analysts, technicians, managers, supervisors, and all other professionals responsible to measure and improve the quality of their processes. Although the examples and case studies presented throughout the book are based on situations found in an organization regulated by FDA, the book can also be used to understand the application of those tools in any type of industry. Readers will obtain a better understanding of some of the statistical tools available to control their processes and be encouraged to study, with a greater level of detail, each of the statistical tools presented throughout the book. The content of this book is the result of the author’s almost 20 years of experience in the application of statistics in various industries, and his combined educational background of engineering and law that he has used to provide consulting services to dozens of FDA-regulated organizations.