Download or read book Handbook of Investigation and Effective CAPA Systems written by Jose (Pepe) Rodriguez-Perez and published by Quality Press. This book was released on 2022-02-15 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Handbook of Investigation and Effective CAPA Systems Second Edition written by José Rodríguez Pérez and published by . This book was released on 2016 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Certified Pharmaceutical GMP Professional Handbook Second Edition written by Mark Allen Durivage and published by Quality Press. This book was released on 2016-05-26 with total page 516 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.
Download or read book Process Monitoring and Improvement Handbook Second Edition written by Manuel E. Peña-Rodríguez and published by Quality Press. This book was released on 2018-08-27 with total page 127 pages. Available in PDF, EPUB and Kindle. Book excerpt: The concept of process monitoring and improvement applies to any type of industry: automotive, textiles, food, pharmaceuticals, biologics, medical devices, electronics, aerospace, banking, educational institutions, service providers, and so on. The focus of this book is to identify and apply different process monitoring and improvement tools in any organization. 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. Many times, these professionals do not have a formal education on the use of these tools but learn about them throughout the different improvement projects in which they are involved in their work environment. This book is intended to fill the gap between the lack of formal education in the tools and the need to implement those tools in an improvement project. The book can also be used as a refresher course for those professionals who did learn about these tools as part of their educational background.
Download or read book The Biomedical Quality Auditor Handbook Third Edition written by Heather Crawford and published by Quality Press. This book was released on 2017-09-08 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 ASQs 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.
Download or read book Human Error Reduction in Manufacturing written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2018-08-27 with total page 191 pages. Available in PDF, EPUB and Kindle. Book excerpt: For many years, we considered human errors or mistakes as the cause of mishaps or problems. In the manufacturing industries, human error, under whatever label (procedures not followed, lack of attention, or simply error), was the conclusion of any quality problem investigation. The way we look at the human side of problems has evolved during the past few decades. Now we see human errors as the symptoms of deeper causes. In other words, human errors are consequences, not causes. The basic objective of this book is to provide readers with useful information on theories, methods, and specific techniques that can be applied to control human failure. It is a book of ideas, concepts, and examples from the manufacturing sector. It presents a comprehensive overview of the subject, focusing on the practical application of the subject, specifically on the human side of quality and manufacturing errors. In other words, the primary focus of this book is human failure, including its identification, its causes, and how it can be reasonably controlled or prevented in the manufacturing industry setting. In addition to including a detailed discussion of human error (the inadvertent or involuntary component of human failure), a chapter is devoted to analysis and discussion related to voluntary (intentional) noncompliance. Written in a direct style, using simple industry language with abundant applied examples and practical references, this book's insights on human failure reduction will improve individual, organizational, and social well-being.
Download or read book Quality Risk Management in the FDA Regulated Industry written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2017-02-21 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001 was revised and now requires that top management promote the use of risk-based thinking. ISO 13485:2016, which specifies the requirements for a quality management system specific to the medical devices industry, also now shows a greater emphasis on risk management and risk-based decision making. In addition, the FDA Food Safety Modernization Act (FSMA) is the most important reform of U.S. food safety laws in more than 70 years. This indispensable book presents a systematic and comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practice or good laboratory practice. All chapters have been updated and revised, and a new chapter has been added to discuss some of the most common pitfalls and misunderstandings regarding risk management, specifically those related to the use of FMEA as the only element of risk management programs. One of the appendices includes 12 case studies, and the companion CD-ROM contains dozens of U.S. FDA and European guidance documents as well as international harmonization documents (ICH and GHTF-IMDRF) related to risk management activities, as well as a 30-question exam (with answers) on the material discussed in the book.
Download or read book Practical Process Validation written by Mark Allen Durivage and published by Quality Press. This book was released on 2016-07-11 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards. The intent of this book is to provide manufacturing quality professionals working in virtually any industry a quick, convenient, and comprehensive guide to properly conduct process validations that meet regulatory and certification requirements. It will aid quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities.
Download or read book Managing Organizational Risk Using the Supplier Audit Program written by Lance B. Coleman, Sr and published by Quality Press. This book was released on 2018-04-06 with total page 117 pages. Available in PDF, EPUB and Kindle. Book excerpt: Risk elimination. Risk management. Risk mitigation. These terms are an increasingly important part of the lexicon of executive-level management as they strive to succeed in a business environment having global competition, geographically diverse suppliers, and new technologies. In this new, globally expansive marketplace, more than 50 percent of value creation is achieved outside of an organizations walls, or, in other words, through their suppliers. This, too, is where the majority of product realization risk lies. This book defines what risk-based thinking is and how to apply it from the perspective of helping manage organizational risk through the supplier audit process. It provides a detailed and useful discussion of the practical application of risk-based supplier auditing principles. It can be a primer for those new to the profession of supplier auditing, and it also shares tips and best practices that would benefit experienced auditors as well. The first section explores supplier management, supplier auditing, and the supplier audit process. The second section discusses the skills, both traditional and nontraditional, needed to ensure a successful supplier audit. Relevant aspects of ASQs Certified Quality Auditor (CQA) and Certified Supplier Quality Professional (CSQP) Bodies of Knowledge are discussed in detail. The authors friends and colleagues from around the globe shared their own stories in Case in Point vignettes interspersed throughout the book, providing first-hand case studies from, among others, the medical device, logistics, automotive, and aerospace industries.
Download or read book Safety Risk Management for Medical Devices written by Bijan Elahi and published by Academic Press. This book was released on 2021-11-11 with total page 541 pages. Available in PDF, EPUB and Kindle. Book excerpt: Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations. Includes new coverage of ISO 14971:2019, ISO/TR 24971 Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation
Download or read book Human Error Reduction in Manufacturing written by Jose (Pepe) Rodriguez-Perez and published by Quality Press. This book was released on 2023-02-13 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: For many years, we considered human errors or mistakes as the cause of mishaps or problems. In the manufacturing industries, human error, under whatever label (procedures not followed, lack of attention, or simply error), was the conclusion of any quality problem investigation. The way we look at the human side of problems has evolved during the past few decades. Now we see human errors as the symptoms of deeper causes. In other words, human errors are consequences, not causes. The basic objective of this book is to provide readers with useful information on theories, methods, and specific techniques that can be applied to control human failure. It is a book of ideas, concepts, and examples from the manufacturing sector. It presents a comprehensive overview of the subject, focusing on the practical application of the subject, specifically on the human side of quality and manufacturing errors. In other words, the primary focus of this book is human failure, including its identification, its causes, and how it can be reasonably controlled or prevented in the manufacturing industry setting. In addition to including a detailed discussion of human error (the inadvertent or involuntary component of human failure), a chapter is devoted to analysis and discussion related to voluntary (intentional) noncompliance. Written in a direct style, using simple industry language with abundant applied examples and practical references, this book's insights on human failure reduction will improve individual, organizational, and social well-being.
Download or read book Root Cause Analysis Second Edition written by Duke Okes and published by Quality Press. This book was released on 2019-02-06 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: This best-seller can help anyone whose role is to try to find specific causes for failures. It provides detailed steps for solving problems, focusing more heavily on the analytical process involved in finding the actual causes of problems. It does this using figures, diagrams, and tools useful for helping to make our thinking visible. This increases our ability to see what is truly significant and to better identify errors in our thinking. In the sections on finding root causes, this second edition now includes: more examples on the use of multi-vari charts; how thought experiments can help guide data interpretation; how to enhance the value of the data collection process; cautions for analyzing data; and what to do if one cant find the causes. In its guidance on solution identification, biomimicry and TRIZ have been added as potential solution identification techniques. In addition, the appendices have been revised to include: an expanded breakdown of the 7 Ms, which includes more than 50 specific possible causes; forms for tracking causes and solutions, which can help maintain alignment of actions; techniques for how to enhance the interview process; and example responses to problem situations that the reader can analyze for appropriateness.
Download or read book CAPA in the Pharmaceutical and Biotech Industries written by J Rodriguez and published by Elsevier. This book was released on 2015-12-08 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: CAPA in the Pharmaceutical and Biotech Industries: How to Implement an Effective Nine Step Program contains the most current information on how to implement, develop, and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a nine step closed-loop process approach for medical devices and pharmaceutical and biologic manufacturers, as well as any anyone who has to maintain a quality system.This book addresses how companies often make the mistake of fixing problems in their processes by revising procedures or, more commonly, by retraining employees that may or may not have caused the problem. This event-focused fix leads to the false assumption that the errors have been eradicated and will be prevented in the future. The reality is that the causes of the failure were never actually determined, therefore the same problem will recur over and over. CAPA is a complete system that collects information regarding existing and potential quality problems. It analyzes and investigates the issues to identify the root cause of nonconformities. It is not just a quick-fix, simple approach, it is a process and has to be understood throughout organizations. Provides an understanding of the principles and techniques involved in the effective implementation of a CAPA program, from the identification of the problem, to the verification of preventive action Emphasis is placed on the practical aspects of how to perform failure investigations and root cause analysis through the use of several types of methodologies, all explained in detail Provides effective methods to use with a Corrective Action system to help quality professionals identify costly issues and resolve them quickly and appropriately
Download or read book Human Error Reduction in Manufacturing written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2018-08-27 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt: For many years, we considered human errors or mistakes as the cause of mishaps or problems. In the manufacturing industries, human error, under whatever label (procedures not followed, lack of attention, or simply error), was the conclusion of any quality problem investigation. The way we look at the human side of problems has evolved during the past few decades. Now we see human errors as the symptoms of deeper causes. In other words, human errors are consequences, not causes. The basic objective of this book is to provide readers with useful information on theories, methods, and specific techniques that can be applied to control human failure. It is a book of ideas, concepts, and examples from the manufacturing sector. It presents a comprehensive overview of the subject, focusing on the practical application of the subject, specifically on the human side of quality and manufacturing errors. In other words, the primary focus of this book is human failure, including its identification, its causes, and how it can be reasonably controlled or prevented in the manufacturing industry setting. In addition to including a detailed discussion of human error (the inadvertent or involuntary component of human failure), a chapter is devoted to analysis and discussion related to voluntary (intentional) noncompliance. Written in a direct style, using simple industry language with abundant applied examples and practical references, this books insights on human failure reduction will improve individual, organizational, and social well-being.
Download or read book Practical Handbook for Professional Investigators Second Edition written by Rory J. McMahon, CLI, CFE and published by CRC Press. This book was released on 2007-02-15 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the publication of the first edition of this volume, many new certification programs have begun in private and community colleges, including a course designed by the author for Boston University and a specialty certification by the U.S. Association for Professional Investigators. Reflecting the surge in interest into the investigative field, this second edition of the bestselling Practical Handbook for Private Investigators contains more than 20 percent new material and has been adopted as required material in several new certification programs. This book describes the range of investigations for which a professional investigator's services might be required, including fraud detection and investigation, surveillance, arson and insurance, skip tracing, and missing persons. Packed with case studies and examples drawn from the author's 33 years of experience, this handy resource covers everything from how to set up, market, and run an agency to the ethics of confidentiality and conflict of interest. It includes sections on how to get licensed, how to use various lo- and high-tech investigative tools including the internet, and how to take statements and implement effective interview and interrogation tactics by the non-law enforcement professional. New information in the second edition includes an updated and revised job description, realistic earning capabilities, and future outlook for the profession; new case studies involving legal investigatory practices and how to navigate the most recent privacy legislation; additional advice on case file management with examples of new paperwork and updated forms; and increased information on fraud and domestic cases, as well as the component method of criminal defense investigations. Designed as an up-to-date, nuts-and-bolts learning tool for students and as a day-to-day reference resource for the investigative professional of any type or level of experience, the Practical Handbook for Professional Investigators, Second Edition provides an unparalleled guide to the ins and outs of the world of today's private investigator.
Download or read book Guidelines Manual written by United States Sentencing Commission and published by . This book was released on 1988-10 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Certified Nurse Educator CNE Review Manual Second Edition written by Ruth Wittmann-Price, PhD, CNS, RN, CNE and published by Springer Publishing Company. This book was released on 2013-05-22 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This is a treasure trove for those preparing for the CNE examination. For those adding certification to their goals list, this book is a must have."--Doody's Medical Reviews "I truly believe that your book made it possible for me to successfully complete the CNE exam! It truly is the only book you need to pass the CNE exam - I'm living proof! Thanks so much! I learned a lot from your book and intend to keep it on my desk for future reference!" -Sue Carroll, MSN, RN Sentara College of Health Sciences This is the only CNE review book for both novice and expert nurse educators that offers a systematic approach to preparing for the CNE Certification Exam. This concise Manual is aligned with the NLNís test blueprint to reflect not only requisite knowledge but also the percentages of content distribution in the new test plan. The book is organized into fifteen chapters that address the core content of topics outlined in the exam blueprint. Additionally, each chapter is organized into bite-size segments to facilitate ease of use. Chapters contains case studies, tips for test success, and critical thinking questions along with web links for accessing additional content on a particular topic. Review questions complete each chapter and a sample CNE test is provided. Three practice tests are also included along with an answer key and rationale for self-assessment. New to the Second Edition: Reflects shifting paradigms in nursing education Focuses on specific change theory, mentoring, incivility, curriculum design, and technology Revises content to reflect the new NLN CNL test plan Includes additional questions and teaching examples
