The Certified Pharmaceutical GMP Professional Handbook Second Edition

Author: Mark Allen Durivage
Publisher: ASQ Quality Press
ISBN: 9780873899338
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.

A Manager s Guide to ISO 22301 Standard for Business Continuity Management System LITE

Author: Dr Goh Moh Heng
Publisher: GMH Continuity Architects
ISBN: 9789810732394
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.

Business Continuity Management System

Author: Wei Ning Zechariah Wong
Publisher: Kogan Page Publishers
ISBN: 9780749469122
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.

Digital Forensics Processing and Procedures

Author: David Lilburn Watson
Publisher: Newnes
ISBN: 9781597497459
Release Date: 2013-08-30
Genre: Computers

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

The Manager s Guide to Simple Strategic Service Oriented Business Continuity

Author: Rachelle Loyear, MBCP, AFBCI, CISM, PMP
Publisher: Rothstein Publishing
ISBN: 9781944480387
Release Date: 2017-05-10
Genre: Business & Economics

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.

Encyclopedia of Crisis Management

Author: K. Bradley Penuel
Publisher: SAGE Publications
ISBN: 9781506354996
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.

Dependability Engineering and Complex Systems

Author: Wojciech Zamojski
Publisher: Springer
ISBN: 9783319396392
Release Date: 2016-06-17
Genre: Computers

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.

Safety and Reliability of Complex Engineered Systems

Author: Luca Podofillini
Publisher: CRC Press
ISBN: 9781315648415
Release Date: 2015-09-03
Genre: Technology & Engineering

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.

Business Continuity Management

Author: Andrew Hiles
Publisher: Rothstein Publishing
ISBN: 9781931332835
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.

MEDINFO 2015 EHealth enabled Health

Author: I.N. Sarkar
Publisher: IOS Press
ISBN: 9781614995647
Release Date: 2015-08-12
Genre: Medical

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.

Business Continuity Management Systems

Author: Hilary Estall
Publisher: BCS, The Chartered Institute
ISBN: 9781780171463
Release Date: 2012
Genre: Business planning

Written for organizations that are implementing a business continuity management system and certification in line with ISO 22301, this guide will prove invaluable for those new to business continuity management or to management systems. Enriched with self-assessment checklists, worksheets, and top tips.

System Safety Engineering and Risk Assessment

Author: Nicholas J. Bahr
Publisher: CRC Press
ISBN: 9781466551602
Release Date: 2014-12-09
Genre: Technology & Engineering

We all know that safety should be an integral part of the systems that we build and operate. The public demands that they are protected from accidents, yet industry and government do not always know how to reach this common goal. This book gives engineers and managers working in companies and governments around the world a pragmatic and reasonable approach to system safety and risk assessment techniques. It explains in easy-to-understand language how to design workable safety management systems and implement tested solutions immediately. The book is intended for working engineers who know that they need to build safe systems, but aren’t sure where to start. To make it easy to get started quickly, it includes numerous real-life engineering examples. The book’s many practical tips and best practices explain not only how to prevent accidents, but also how to build safety into systems at a sensible price. The book also includes numerous case studies from real disasters that describe what went wrong and the lessons learned. See What’s New in the Second Edition: New chapter on developing government safety oversight programs and regulations, including designing and setting up a new safety regulatory body, developing safety regulatory oversight functions and governance, developing safety regulations, and how to avoid common mistakes in government oversight Significantly expanded chapter on safety management systems, with many practical applications from around the world and information about designing and building robust safety management systems, auditing them, gaining internal support, and creating a safety culture New and expanded case studies and "Notes from Nick’s Files" (examples of practical applications from the author’s extensive experience) Increased international focus on world-leading practices from multiple industries with practical examples, common mistakes to avoid, and new thinking about how to build sustainable safety management systems New material on safety culture, developing leading safety performance indicators, safety maturity model, auditing safety management systems, and setting up a safety knowledge management system