Pharmaceutical Microbiological Quality Assurance and Control


Book Description

Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks




The Handbook of Quality Management 2e (Pb)


Book Description

Publisher's Note: Products purchased from Third Party sellers are not guaranteed by the publisher for quality, authenticity, or access to any online entitlements included with the product. The definitive guide to organizational excellence--completely updated Fully revised for the latest American Society for Quality (ASQ) Certified Manager of Quality/Organizational Excellence (CMQ/QE) Body of Knowledge, The Handbook for Quality Management: A Complete Guide to Operational Excellence, Second Edition offers in-depth guidance on effectively applying the principles of quality management in today's business environment and delivering superior results. Designed to help you prepare for and pass the ASQ CMQ/QE exam, this authoritative volume also serves as an essential on-the-job reference. Coverage includes: Business-integrated quality systems Organizational structures The quality function Approaches to quality Customer-focused organizations Integrated planning Strategic planning Understanding customer expectations and needs Benchmarking Organizational assessment Process control Quantifying process variation Quality audits Supply chain management Continuous improvement Effective change management Six Sigma methodology, including detailed descriptions of the DMAIC and DMADV approaches Management of human resources Motivation theories and principles Management styles Resource requirements to manage the quality function Over the past 40 years, the quality management discipline has undergone steady evolution from disparate quality assurance efforts to strategic, business-integrated functions. Today's quality manager must be able to plan and implement measurable, cost-effective process-improvement initiatives across the organization. Written by two of the foremost authorities on the subject and fully updated for the latest American Society for Quality (ASQ) Certified Manager of Quality/Organizational Excellence (CMQ/OE) Body of Knowledge, The Handbook for Quality Management, Second Edition provides an operational guide to the proper understanding and application of quality management in the current business environment. It serves as a primary reference source for an organization's quality program and for anyone seeking to pass the CMQ/OE exam, given by the ASQ. The Handbook for Quality Management: A Complete Guide to Operational Excellence, Second Edition: Clearly defines quality management principles and their application within a cross section of industries Integrates the application of Theory of Constraints, Six Sigma, and Lean thinking into the Quality Management discipline Contains detailed methods for planning, including customer needs recognition, benchmarking, and organizational assessments Discusses controls such as statistical process control, audits, and supply chain management Explains the stages of continuous improvement Incorporates classic motivation theory with more current management practices advocated by Joiner, Senge, and Deming, among others




Juran's Quality Handbook: The Complete Guide to Performance Excellence, Seventh Edition


Book Description

Publisher's Note: Products purchased from Third Party sellers are not guaranteed by the publisher for quality, authenticity, or access to any online entitlements included with the product. The cornerstone text on quality management and performance excellence – thoroughly revised to reflect the latest challenges and developments The “body of knowledge” for the science of quality management and performance excellence for more than half-a-century, Juran’s Quality Handbook has been completely updated to meet the ever-changing needs of today’s business and quality professionals. Under the guidance of a team of top experts, this authoritative resource demonstrates how to apply the right methods for delivering superior results and achieving excellence in any organization, industry, or country. Juran’s Quality Handbook, Seventh Edition provides you with a complete roadmap for the discipline -- clearly written to make sure you know where you are in the process and what you must do to reach the next level. Within its pages, you will find A-Z coverage – from key concepts, methods, research, and tools to practical applications on the job. Here’s why this is the best edition yet: • Updated chapters on Lean, Six Sigma and the Shingo Prize • NEW chapters on Risk Management and Building a Quality Management System • NEW material on the history of quality management • All ISO and other regulatory standards have been updated • NEW statistical tables, charts, and data • Examples and case studies throughout demonstrate how others have applied the methods and tools discussed in real-world situations




A Guide for Machine Vision in Quality Control


Book Description

Machine Vision systems combine image processing with industrial automation. One of the primary areas of application of Machine Vision in the Industry is in the area of Quality Control. Machine vision provides fast, economic and reliable inspection that improves quality as well as business productivity. Building machine vision applications is a challenging task as each application is unique, with its own requirements and desired outcome. A Guide to Machine Vision in Quality Control follows a practitioner’s approach to learning machine vision. The book provides guidance on how to build machine vision systems for quality inspections. Practical applications from the Industry have been discussed to provide a good understanding of usage of machine vision for quality control. Real-world case studies have been used to explain the process of building machine vision solutions. The book offers comprehensive coverage of the essential topics, that includes: Introduction to Machine Vision Fundamentals of Digital Images Discussion of various machine vision system components Digital image processing related to quality control Overview of automation The book can be used by students and academics, as well as by industry professionals, to understand the fundamentals of machine vision. Updates to the on-going technological innovations have been provided with a discussion on emerging trends in machine vision and smart factories of the future. Sheila Anand is a PhD graduate and Professor at Rajalakshmi Engineering College, Chennai, India. She has over three decades of experience in teaching, consultancy and research. She has worked in the software industry and has extensive experience in development of software applications and in systems audit of financial, manufacturing and trading organizations. She guides Ph.D. aspirants and many of her research scholars have since been awarded their doctoral degree. She has published many papers in national and international journals and is a reviewer for several journals of repute. L Priya is a PhD graduate working as Associate Professor and Head, Department of Information Technology at Rajalakshmi Engineering College, Chennai, India. She has nearly two decades of teaching experience and good exposure to consultancy and research. She has delivered many invited talks, presented papers and won several paper awards in International Conferences. She has published several papers in International journals and is a reviewer for SCI indexed journals. Her areas of interest include Machine Vision, Wireless Communication and Machine Learning.




Laboratory Quality Management System


Book Description

Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to engage in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook was developed through collaboration between the WHO Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute (CLSI). It is based on training sessions and modules provided by the CDC and WHO in more than 25 countries, and on guidelines for implementation of ISO 15189 in diagnostic laboratories, developed by CLSI. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. Each topic is discussed in a separate chapter. The chapters follow the framework developed by CLSI and are organized as the "12 Quality System Essentials".




ISO 13485:2016


Book Description

Summary: This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more than 800-page length, the author has specifically designed its contents to maximize usability for the reader with a table of contents identical to that of the ISO standard itself, which enables easy navigation and orientation. Pragmatic in style and down to earth in tone, this book draws real-life examples and case-studies from the author’s many years of experience in consulting to illustrate even the most complex of ISO 13485:2016 standard requirements and their implementation. Identifying relevant requirements and how they harmonize with quality management systems, developing processes for design and development, as well as product realization and validation are just a few of the issues covered in-depth by this publication. In addition, the author constantly reviews the distinctive characteristics and aspects of the medical device manufacturing industry, so that the reader can also appreciate the subject of this book in an everyday context. Features: A pragmatic and down to earth approach towards the reader’s understanding of ISO 13485:2016 standard requirements implementation. Uses examples and cases from real-life based on the author’s many years of experience in quality management. A table of contents structured identically to that of ISO 13485:2016 itself, allowing easier navigation and orientation for the reader. Emphasises guidance for ISO 13495:2016 standard requirements which are difficult to interpret and implement Constantly reviews the aspect of medical device industry characteristics and distinctive so the reader can reflect the content with its daily work.




Measuring Quality Improvement in Healthcare


Book Description

This ground-breaking book addresses the critical, growing need among health care administrators and practitioners to measure the effectiveness of quality improvement efforts. Written by respected healthcare quality professionals, Measuring Quality Improvement in Healthcare covers practical applications of the tools and techniques of statistical process control (SPC), including control charts, in healthcare settings. The authors' straightforward discussions of data collection, variation, and process improvement set the context for the use and interpretation of control charts. Their approach incorporates "the voice of the customer" as a key element driving the improvement processes and outcomes. The core of the book is a set of 12 case studies that show how to apply statistical thinking to health care process, and when and how to use different types of control charts. The practical, down-to-earth orientation of the book makes it accessible to a wide readership. "Only authors who have used statistics and control charts to solve real-world healthcare problems could have written a book so practical and timely." - Barry S. Bader, Publisher The Quality Letter for Healthcare Leaders "Many clinicians and other healthcare leaders underestimate the great contributions that better statistical thinking could make toward reducing costs and improving outcomes. This fascinating and timely book is a fine guide for getting started." - Donald M. Berwick, M.D. President and CEO, Institute for Healthcare Improvement Associate Professor of Pediatrics, Harvard Medical School Contents: Planning Your CQI Journey, Preparing to Collect Data, Data Collection, Understanding Variation, Using Run and Control Charts to Analyze Process Variation, Control Chart Case Studies, Developing Improvement Strategies, Using Patient Surveys for CQI, Formulas for Calculating Control Limits




Juran's Quality Handbook


Book Description

For decades, Juran's Quality Handbook has been the one essential reference in quality management and engineering—the ultimate authoritative source of answers on quality applications, procedures, techniques, and strategies. Now this Fifth Edition—a major revision and the first new edition of Juran's Quality Handbook in more than 10 years—forges a new standard in tools for quality. Bringing managers and engineers the most up-to-date methods, research, and theory, under the guidance of a team of the world's top experts, Juran's shows you how to plan for quality, achieve quality control, and ensure quality results. Packed with new methods, research, and thought on quality, and emphasizing the need for quality software and quality software development methods, this completely updated classic also gives you new information, new techniques, and new applications. Broad in scope and inclusive in methodology, Juran's Quality Handbook is the reference of choice for anyone concerned with quality in business, manufacturing, or engineering. Whether you're just beginning your journey or a longtime traveler on the quality path, this book is the best possible companion for your voyage.




Introduction to Statistical Quality Control


Book Description

Once solely the domain of engineers, quality control has become a vital business operation used to increase productivity and secure competitive advantage. Introduction to Statistical Quality Control offers a detailed presentation of the modern statistical methods for quality control and improvement. Thorough coverage of statistical process control (SPC) demonstrates the efficacy of statistically-oriented experiments in the context of process characterization, optimization, and acceptance sampling, while examination of the implementation process provides context to real-world applications. Emphasis on Six Sigma DMAIC (Define, Measure, Analyze, Improve and Control) provides a strategic problem-solving framework that can be applied across a variety of disciplines. Adopting a balanced approach to traditional and modern methods, this text includes coverage of SQC techniques in both industrial and non-manufacturing settings, providing fundamental knowledge to students of engineering, statistics, business, and management sciences. A strong pedagogical toolset, including multiple practice problems, real-world data sets and examples, and incorporation of Minitab statistics software, provides students with a solid base of conceptual and practical knowledge.