Author: Mark Allen Durivage
Publisher: ASQ Quality Press
Release Date: 2016-05-26
Genre: Business & Economics
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.
Author: Dr Goh Moh Heng
Publisher: GMH Continuity Architects
Release Date: 2013
Genre: Business planning
This book is written for those who are new to Business Continuity Management (BCM) and also as a reference for practitioners, who are assigned to initiate the BC planning (BCP) project in their organization using the ISO 22301 Standard for Business Continuity Management System (BCMS). It applies the author's experiences in getting several clients' organizations to successfully achieve the ISO22301 BCMS certification. This books is also for seasoned BCM professional to guide you through the BCM implementation process.
Author: Wei Ning Zechariah Wong
Publisher: Kogan Page Publishers
Release Date: 2014-11-03
Genre: Business & Economics
A business continuity management system (BCMS) is a management framework that prepares the organization by developing business continuity strategies to meet its business and statutory obligations during an incident. It is about optimizing service availability and preserving business performance to secure future growth in the market. Business Continuity Management System offers a complete guide to establishing a fit-for-purpose business continuity capability in your organization. Structured in line with the principles of ISO22301 (the International Standard for business continuity management) and with current best practice, this user-friendly book covers the whole life cycle of developing, establishing, operating and evaluating a BCMS initiative. It is aimed at new and seasoned business continuity practitioners involved in business continuity activities in their organizations, whatever the size and sector. It includes proven techniques and easy-to-use methodologies that specifically support the implementation of those requirements specified in ISO 22301. Pragmatic approaches supported by in-depth explanations guide you to assess and improve your organization's BCMS performance. This is the first book to offer an end-to-end solution that addresses all aspects of implementing an effective BCMS. Business Continuity Management System is intended to act as a catalyst to accelerate progress on the journey from business continuity management and risk management to the creation and implementation of a business continuity management system, both by enhancing the BCM and risk competence of individual readers and by contributing to shared knowledge in implementing ISO 22301 in organizations.
Author and experienced business continuity consultant Dejan Kosutic has written Becoming Resilient with one goal in mind: to give you the knowledge and practical step-by-step processes you need to successfully implement ISO 22301—without any stress, hassle or headaches. This book is written for beginners in the field and is structured in such a way that someone with no prior experience or knowledge about business continuity. It will help you fully understand the subject and implement an entire business continuity project. If you are an IT administrator, information security professional, quality manager, or a project manager with a task to implement ISO 22301 in your company, this book is perfect for you. However, this book will be also useful for consultants and experienced business continuity practitioners. It can be used as a checklist for getting a comprehensive and structured view of how business continuity should be implemented. Becoming Resilient is a step-by-step guide that takes you from an introduction of ISO 22301 to the implementation of the business continuity standard. During the process, Dejan uses plain English to explain: • Common misunderstandings of the standard: “Business continuity is a job for IT guys;” “Business continuity equals business continuity plans;” “Business continuity is a one-time job;” and others. • How to present the benefits to your top management: “Reason number one for business continuity project failures? The number one problem most business continuity practitioners are emphasizing? The answer is the same – lack of management understanding and commitment.” • How to develop a Business Impact Analysis Methodology, an Incident Response Plan, a Business Recovery plan and other crucial actions to implement and maintain the ISO 22301 standard. Leaving the technical jargon to the geeks, Becoming Resilient is written for everyone, using plain, simple language. Whether you’re a business continuity practitioner or new to the field, it’s the only book you’ll ever need on the subject of ISO 22301 implementation.
This is the first digital forensics book that covers the complete lifecycle of digital evidence and the chain of custody. This comprehensive handbook includes international procedures, best practices, compliance, and a companion web site with downloadable forms. Written by world-renowned digital forensics experts, this book is a must for any digital forensics lab. It provides anyone who handles digital evidence with a guide to proper procedure throughout the chain of custody--from incident response through analysis in the lab. A step-by-step guide to designing, building and using a digital forensics lab A comprehensive guide for all roles in a digital forensics laboratory Based on international standards and certifications
Author: Andrew Hiles
Publisher: Rothstein Publishing
Release Date: 2014-09-30
Genre: Business & Economics
At this critical point in your Business Continuity Management studies and research, you need one definitive, comprehensive professional textbook that will take you to the next step. In his 4th edition of Business Continuity Management: Global Best Practices, Andrew Hiles gives you a wealth of real-world analysis and advice – based on international standards and grounded in best practices -- a textbook for today, a reference for your entire career. With so much to learn in this changing profession, you don't want to risk missing out on something you’ll need later. Does one of these describe you? Preparing for a Business Continuity Management career, needing step-by-step guidelines, Working in BCM, looking to deepen knowledge and stay current -- and create, update, or test a Business Continuity Plan. Managing in BCM, finance, facilities, emergency preparedness or other field, seeking to know as much as much as possible to make the decisions to keep the company going in the face of a business interruption. Hiles has designed the book for readers on three distinct levels: Initiate, Foundation, and Practitioner. Each chapter ends with an Action Plan, pinpointing the primary message of the chapter and a Business Continuity Road Map, outlining the actions for the reader at that level. NEW in the 4th Edition: Supply chain risk -- extensive chapter with valuable advice on contracting. Standards -- timely information and analysis of global/country-specific standards, with detailed appendices on ISO 22301/22313 and NFPA 1600. New technologies and their impact – mobile computing, cloud computing, bring your own device, Internet of things, and more. Case studies – vivid examples of crises and disruptions and responses to them. Horizon scanning of new risks – and a hint of the future of BCM. Professional certification and training – explores issues so important to your career. Proven techniques to win consensus on BC strategy and planning. BCP testing – advice and suggestions on conducting a successful exercise or test of your plan To assist with learning -- chapter learning objectives, case studies, real-life examples, self-examination and discussion questions, forms, checklists, charts and graphs, glossary, and index. Downloadable resources and tools – hundreds of pages, including project plans, risk analysis forms, BIA spreadsheets, BC plan formats, and more. Instructional Materials -- valuable classroom tools, including Instructor’s Manual, Test Bank, and slides -- available for use by approved adopters in college courses and professional development training.
You have the knowledge and skill to create a workable Business Continuity Management (BCM) program – but too often, your projects are stalled while you attempt to get the right information from the right person. Rachelle Loyear experienced these struggles for years before she successfully revamped and reinvented her company’s BCM program. In The Manager’s Guide to Simple, Strategic, Service-Oriented Business Continuity, she takes you through the practical steps to get your program back on track. Rachelle Loyear understands your situation well. Her challenge was to manage BCM in a large enterprise that required hundreds of BC plans to be created and updated. The frustrating reality she faced was that subject matter experts in various departments held the critical information she needed, but few were willing to write their parts of the plan. She tried and failed using all the usual methods to educate and motivate – and even threaten – departments to meet her deadlines. Finally, she decided there had to be a better way. The result was an incredibly successful BCM program that was adopted by BCM managers in other companies. She calls it “The Three S’s of BCM Success,” which can be summarized as: Simple – Strategic – Service-Oriented. Loyear’s approach is easy and intuitive, considering the BCM discipline from the point of view of the people in your organization who are tasked to work with you on building the plans and program. She found that most people prefer: Simple solutions when they are faced with something new and different. Strategic use of their time, making their efforts pay off. Service to be provided, lightening their part of the load while still meeting all the basic requirements. These tactics explain why the 3S program works. It helps you, it helps your program, and it helps your program partners. Loyear says, “If you follow the ‘Three S’ philosophy, the number of plans you need to document will be fewer, and the plans will be simpler and easier to produce. I’ve seen this method succeed repeatedly when the traditional method of handing a business leader a form to fill out or a piece of software to use has failed to produce quality plans in a timely manner.” In The Manager’s Guide to Simple, Strategic, Sevice-Oriented Business Continuity, Loyear shows you how to: Completely change your approach to the problems of “BCM buy-in.” Find new ways to engage and support your BCM program partners and subject matter experts. Develop easier-to-use policies, procedures, and plans. Improve your overall relationships with everyone involved in your BCM program. Craft a program that works around the roadblocks rather than running headlong into them.
Safety and Reliability – Theory and Applications contains the contributions presented at the 27th European Safety and Reliability Conference (ESREL 2017, Portorož, Slovenia, June 18-22, 2017). The book covers a wide range of topics, including: • Accident and Incident modelling • Economic Analysis in Risk Management • Foundational Issues in Risk Assessment and Management • Human Factors and Human Reliability • Maintenance Modeling and Applications • Mathematical Methods in Reliability and Safety • Prognostics and System Health Management • Resilience Engineering • Risk Assessment • Risk Management • Simulation for Safety and Reliability Analysis • Structural Reliability • System Reliability, and • Uncertainty Analysis. Selected special sessions include contributions on: the Marie Sk?odowska-Curie innovative training network in structural safety; risk approaches in insurance and fi nance sectors; dynamic reliability and probabilistic safety assessment; Bayesian and statistical methods, reliability data and testing; oganizational factors and safety culture; software reliability and safety; probabilistic methods applied to power systems; socio-technical-economic systems; advanced safety assessment methodologies: extended Probabilistic Safety Assessment; reliability; availability; maintainability and safety in railways: theory & practice; big data risk analysis and management, and model-based reliability and safety engineering. Safety and Reliability – Theory and Applications will be of interest to professionals and academics working in a wide range of industrial and governmental sectors including: Aeronautics and Aerospace, Automotive Engineering, Civil Engineering, Electrical and Electronic Engineering, Energy Production and Distribution, Environmental Engineering, Information Technology and Telecommunications, Critical Infrastructures, Insurance and Finance, Manufacturing, Marine Industry, Mechanical Engineering, Natural Hazards, Nuclear Engineering, Offshore Oil and Gas, Security and Protection, Transportation, and Policy Making.
Author: K. Bradley Penuel
Publisher: SAGE Publications
Release Date: 2013-02-14
Genre: Business & Economics
Although now a growing and respectable research field, crisis management—as a formal area of study—is relatively young, having emerged since the 1980s following a succession of such calamities as the Bhopal gas leak, Chernobyl nuclear accident, Space Shuttle Challenger loss, and Exxon Valdez oil spill. Analysis of organizational failures that caused such events helped drive the emerging field of crisis management. Simultaneously, the world has experienced a number of devastating natural disasters: Hurricane Katrina, the Japanese earthquake and tsunami, etc. From such crises, both human-induced and natural, we have learned our modern, tightly interconnected and interdependent society is simply more vulnerable to disruption than in the past. This interconnectedness is made possible in part by crisis management and increases our reliance upon it. As such, crisis management is as beneficial and crucial today as information technology has become over the last few decades. Crisis is varied and unavoidable. While the examples highlighted above were extreme, we see crisis every day within organizations, governments, businesses and the economy. A true crisis differs from a "routine" emergency, such as a water pipe bursting in the kitchen. Per one definition, "it is associated with urgent, high-stakes challenges in which the outcomes can vary widely (and are very negative at one end of the spectrum) and will depend on the actions taken by those involved." Successfully engaging, dealing with, and working through a crisis requires an understanding of options and tools for individual and joint decision making. Our Encyclopedia of Crisis Management comprehensively overviews concepts and techniques for effectively assessing, analyzing, managing, and resolving crises, whether they be organizational, business, community, or political. From general theories and concepts exploring the meaning and causes of crisis to practical strategies and techniques relevant to crises of specific types, crisis management is thoroughly explored. Features & Benefits: A collection of 385 signed entries are organized in A-to-Z fashion in 2 volumes available in both print and electronic formats. Entries conclude with Cross-References and Further Readings to guide students to in-depth resources. Selected entries feature boxed case studies, providing students with "lessons learned" in how various crises were successfully or unsuccessfully managed and why. Although organized A-to-Z, a thematic "Reader's Guide" in the front matter groups related entries by broad areas (e.g., Agencies & Organizations, Theories & Techniques, Economic Crises, etc.). Also in the front matter, a Chronology provides students with historical perspective on the development of crisis management as a discrete field of study. The work concludes with a comprehensive Index, which—in the electronic version—combines with the Reader's Guide and Cross-References to provide thorough search-and-browse capabilities. A template for an "All-Hazards Preparedness Plan" is provided the backmatter; the electronic version of this allows students to explore customized response plans for crises of various sorts. Appendices also include a Resource Guide to classic books, journals, and internet resources in the field, a Glossary, and a vetted list of crisis management-related degree programs, crisis management conferences, etc.
Safety and Reliability of Complex Engineered Systems contains the Proceedings of the 25th European Safety and Reliability Conference, ESREL 2015, held 7-10 September 2015 in Zurich, Switzerland. It includes about 570 papers accepted for presentation at the conference. These contributions focus on theories and methods in the area of risk, safety and reliability, and their applications to a wide range of industrial, civil and social sectors. The main goal of this book is to showcase the advancements in understanding, modeling and management of complex engineered systems. The book offers a multidisciplinary platform to address technological, societal and financial aspects of system safety and reliability. Emphasis is given to the intra- and interdependencies of functions and the cascading failures that characterize complex engineered systems. Safety and Reliability of Complex Engineered Systems (abstracts book 730 pages + full paper CD-ROM 4634 pages) will be of interest to academics and professionals involved or interested in aspect of risk, safety and reliability in various engineering areas.
These proceedings present the results of the Eleventh International Conference on Dependability and Complex Systems DepCoS-RELCOMEX which took place in a picturesque Brunów Palace in Poland from 27th June to 1st July, 2016. DepCoS-RELCOMEX is a series of international conferences organized annually by Department of Computer Engineering of Wrocław University of Science and Technology since 2006. The roots of the series go as far back as to the seventies of the previous century – the first RELCOMEX conference took place in 1977 – and now its main aim is to promote a multi-disciplinary approach to dependability problems in theory and engineering practice of complex systems. Complex systems, nowadays most often computer-based and distributed, are built upon a variety of technical, information, software and human resources. The challenges in their design, analysis and maintenance not only originate from the involved technical and organizational structures but also from the complexity of the information processes that must be efficiently executed in a diverse, often hostile operational environment. Traditional methods of reliability evaluation focused only on technical resources are usually insufficient in this context and more innovative, multidisciplinary methods of dependability analysis must be applied. The diversity of the topics which need to be considered is well illustrated by the selection of the submissions in these proceedings with their subjects ranging from mathematical models and design methodologies through software engineering and data security issues up to practical problems in technical, e.g. transportation, systems.
Health and Biomedical Informatics is a rapidly evolving multidisciplinary field; one in which new developments may prove crucial in meeting the challenge of providing cost-effective, patient-centered healthcare worldwide. This book presents the proceedings of MEDINFO 2015, held in São Paulo, Brazil, in August 2015. The theme of this conference is ‘eHealth-enabled Health’, and the broad spectrum of topics covered ranges from emerging methodologies to successful implementations of innovative applications, integration and evaluation of eHealth systems and solutions. Included here are 178 full papers and 248 poster abstracts, selected after a rigorous review process from nearly 800 submissions by 2,500 authors from 59 countries. The conference brings together researchers, clinicians, technologists and managers from all over the world to share their experiences on the use of information methods, systems and technologies to promote patient-centered care, improving patient safety, enhancing care outcomes, facilitating translational research and enabling precision medicine, as well as advancing education and skills in Health and Biomedical Informatics. This comprehensive overview of Health and Biomedical Informatics will be of interest to all those involved in designing, commissioning and providing healthcare, wherever they may be.
Dieser Herausgeberband gibt einen anwenderorientierten Überblick über die Arbeit von Führungs- und Krisenstäben, ihre Voraussetzungen und Erfolgsbedingungen. Ein interdisziplinäres Autorenteam stellt neben Grundlagen (Konzepte, Formen, Historie, Ethik) wichtige Prozesse und Strategien der Stabsarbeit zur Bewältigung komplexer Schadenslagen oder Einsatzsituationen in den Bereichen Militär, Polizei, Feuerwehr, Katastrophenabwehr, Störfall- & Prozessindustrie, Verwaltung, Unternehmen und Politik vor: Planung und Kontrolle, Lagebesprechungen, Entscheidungen, Stress, Kommunikation und Informationsflüsse, Personalauswahl, Ausbildung und Training sowie Konzepte zur Gestaltung von Stabsräumen. - Ein umfassendes Handbuch für Stabsmitglieder und Entscheider an der Spitze eines Stabes, Personalleitungen und Führungskräfte.
Dieses Buch behandelt das Management der Informationssicherheit auf der Basis der neuen Fassung der Norm ISO/IEC 27001. Die Autoren erläutern kompetent den Standard und seine organisatorisch-technische Umsetzung. Dies betrifft die Anforderungen an das Informationssicherheits-Managementsystem (ISMS) genauso wie die 114 Controls aus dem Anhang der Norm. Die ausführlich kommentierten Controls unterstützen Sicherheitsverantwortliche bei der Auswahl geeigneter Sicherheitsmaßnahmen in allen Bereichen.Die Normenreihe ISO 27000 ist ein wichtiges Hilfsmittel für Unternehmen und Behörden, die ein IT-Sicherheitsmanagement in ihrer Organisation einführen und betreiben wollen. Im internationalen Kontext ist die Anwendung der ISO 27001 für viele Organisationen nahezu unverzichtbar. Nicht zuletzt mit dem deutschen IT-Sicherheitsgesetz erhält dieser Standard auch national eine hohe Bedeutung. Mit der Neufassung der Norm im Jahr 2015 (deutsche Version) müssen sich alle Organisationen entsprechend umstellen und ihr ISMS anpassen. Hierfür enthält das Buch einen entsprechenden „Fahrplan“.