Pharmaceutical Microbiological Quality Assurance and Control PDF Download
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Author: David Roesti
Publisher: John Wiley & Sons
ISBN: 1119356075
Category : Technology & Engineering
Languages : en
Pages : 594
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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
Author: David Roesti
Publisher: John Wiley & Sons
ISBN: 1119356075
Category : Technology & Engineering
Languages : en
Pages : 594
Get Book Here
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
Author: Joseph A. Defeo
Publisher: McGraw-Hill Education
ISBN: 9781259643613
Category : Technology & Engineering
Languages : en
Pages : 0
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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
Author: World Health Organization
Publisher:
ISBN: 9789241548274
Category : Laboratories
Languages : en
Pages : 0
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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".
Author: J. M. Juran
Publisher: McGraw Hill Professional
ISBN: 0071386874
Category : Technology & Engineering
Languages : en
Pages : 24
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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.
Author: Tiffany Roy
Publisher: CRC Press
ISBN: 1498753930
Category : Law
Languages : en
Pages : 241
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Book Description
In 2009, the National Academy of Sciences (NAS) authored the report Strengthening Forensic Science in the United States: A Path Forward. In it, the Committee expressed the need for accreditation and certification. Accreditation, long recognized by public labs as an important benchmark in quality, was recognized as an important way to standardize laboratories that provide forensic services. Certification can play an important role as a method of oversight in the forensic sciences—something also recommended by the - National Commission on Forensic Science in October 2014. The Complete Guide to the ABC's Molecular Biology is a professional certification examination preparation text for forensic scientists taking the American Board of Criminalistics Examination in Molecular Biology. The book serves as a resource for forensic scientists—who are facing more and more pressure to become certified—to support them in their pursuit of forensic certification. In the years since the NAS report was published, there has been increased discussion of forensic certification requirements. ABC’s Molecular Biology exam is a quality certification, and learning the concepts for it will invariably help any professional working in the field. The book prepares readers in all relevant topic areas, including: accreditation, safety, biological screen principles, anatomy and cell biology, crime scene and evidence handling, concepts in genetics, biochemistry, statistics, DNA evidence, and DNA testing. The book will be particularly helpful for forensic science laboratory technicians, police and investigations professionals, forensic serology and DNA analysts, attorneys, and forensic science students. This study guide follows the guidelines for the exam and presents all the information necessary to prepare individuals to pass the exam.
Author:
Publisher: BoD – Books on Demand
ISBN: 0850140242
Category : Technology & Engineering
Languages : en
Pages : 312
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Book Description
In any engineering field (including manufacturing, construction, transportation, aerospace, food and agriculture, oil and gas, etc.), ensuring product quality is fundamental to achieving success. Quality assurance (QA) and quality control (QC) are integral components of managing quality. According to the American Society for Quality (ASQ), QA is defined as the part of quality management that focuses on instilling confidence in meeting quality requirements, while QC is concerned with fulfilling those requirements. QA instills confidence internally within the engineering organization’s management and externally with customers, government agencies, regulators, certifiers, and other stakeholders. QA primarily examines how processes are carried out or how products are made, while QC concentrates on product inspection. When QA and QC collaborate effectively, organizational efficiency is enhanced, resulting in superior products. Quality Control and Quality Assurance - Techniques and Applications explores various aspects of quality, including quality planning, QC, QA, and quality enhancement. It covers topics related to QA such as total quality management (TQM), failure testing, process and product quality assurance (PPQA), and statistical process control (SPC). QC includes chapters describing process control, control charts, acceptance sampling, and product quality assessment. For meaningful and easy traceability, the chapters are divided into four sections: “Basics of QA/QC”; “Applications of QA/QC in Industry”; “Applications of QA/QC in Healthcare”; and “Applications of QA/QC in Education”. Covering the latest practices, techniques, and applications in QC and QA, this book is a valuable resource for engineering and business students, practicing engineers, engineering managers, and third-party agencies.
Author: Shaun R. Opie
Publisher: Springer Nature
ISBN: 3030627160
Category : Medical
Languages : en
Pages : 325
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Book Description
The legislative requirement for cannabis to undergo laboratory testing has followed legalization of medical and recreational use in every U.S. state to date. Cannabis safety testing is a new investment opportunity within the emerging cannabis market that is separate from cultivation, processing, and distribution, allowing individuals and organizations who may have been reluctant to enter previously a new entry route to the cannabis space. However, many of the costs, timelines, operational requirements, and compliance issues are overlooked by people who have not been exposed to regulated laboratory testing. Cannabis Laboratory Fundamentals provides an in-depth review of the key issues that impact cannabis testing laboratories and provides recommendations and solutions to avoid common – but expensive – mistakes. The text goes beyond methodology to include sections on economics, regulation, and operational challenges, making it useful for both new and experienced cannabis laboratory operators, as well as all those who want to understand the opportunities and risks of this industry.
Author: Mary McShane-Vaughn
Publisher: Quality Press
ISBN: 1636940242
Category : Business & Economics
Languages : en
Pages : 1010
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Book Description
Fully updated to reflect the 2022 ASQ Certified Six Sigma Black Belt (CSSBB) Body of Knowledge (BoK), The ASQ Certified Six Sigma Black Belt Handbook, Fourth Edition is ideal for candidates studying for the CSSBB examination. This comprehensive reference focuses on the core areas of organization-wide planning and deployment, team management, and each of the DMAIC project phases. The fourth edition of this handbook offers thorough explanations of statistical concepts in a straightforward way. It also reflects the latest technology and applications of Six Sigma and lean tools. Updates you will find in the fourth edition include: • New topics and tools, such as return on investment calculations, the roles of coaching and finance in projects, process-decision program charts, interrelationship digraphs, A3 analysis, maturity models, key behavior indicators, and audit MSA • A new chapter on risk analysis and management • Revamped statistics sections • New tables, figures, and examples to help illustrate key points The ASQ Certified Six Sigma Black Belt Handbook, Fourth Edition is also a valuable addition to any quality practitioner’s library.
Author: Bert Hedeman
Publisher: Van Haren
ISBN: 9401810931
Category : Architecture
Languages : en
Pages : 569
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Book Description
IPMA observes an increasing number and importance of projects in business, public and people’s lives, also known as ‘projectification’. In the world of globalisation, an increasing number of organisations are working project-based to cope with the challenges of modern times. Especially now, society is on the brink of such significant changes as global warming and artificial intelligence. Projects drive the development of new products and services, expansions, new capabilities, implementation of new strategies and new generations of infrastructure, and major maintenance and upgrade of existing facilities and infrastructure. This book provides a knowledge base for developing individual competencies for managing projects as described in the IPMA Individual Competence Baseline version 4, which encompasses: - Perspective competencies - People competencies - Practice competencies As projects become increasingly important, we must continue to realise that projects begin and end with people and that their competent performance within the broader context of the environment is at the heart of any successful project. In this book, theories and practices for all ICB4 competencies are described. They are logically sequenced, explained and enriched with practical approaches, which can be learned and applied in the daily project management practice. As such, it aligns entirely with IPMA's vision: to strengthen competence across society to enable a world in which all projects succeed. This book also supports obtaining an IPMA certificate as proof of your competence in projects.
Author: Jose Machado
Publisher: Springer Nature
ISBN: 3031615824
Category :
Languages : en
Pages : 455
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Book Description
