Janet Gough - Böcker

A well-understood tenet exists among the FDA and other regulatory bodies: if you didn't write it down, it didn't happen. And if it didn't happen, your company stands to lose time, money, and perhaps its competitive edge. Write it Down: Guidance for Preparing Effective and Compliant Documentation provides you with the tools you need to put effective documentation in place. The book has a three-pronged focus: to help writers understand the why of what they must write and the current industry standards for good documentation practices, to provide effective examples of a broad spectrum of documents, and to supply an in-depth explanation of grammar and punctuation conventions.Substantially expanded, the second edition focuses on the regulations, the need to document, and the range of documentation that must be in place to support therapeutic products from discovery through market. Readers will find useful examples of good writing, many provided by people in the industry. Letters and memos; short reports of varied topics, including equipment evaluation, vendor audit, and trip review; standard operating procedures, laboratory methods, and training materials; documentation for an IQ/OQ/PQ project; a journal article; and excerpts from a development report and a dossier are among the many examples. The book also gives a thorough explanation of grammar, punctuation, and usage, with a strong emphasis on the components of the language that pose difficulties for non-native writers of English.This book is a must for people working in or preparing to work in environments that produce drugs, medical devices, or biologics for sale in countries that have stringent regulatory requirements and where the business language is English. Firmly placing the writing task in context of the existing laws and guidances, the book offers valuable insights into managing systems and producing documentation that meets the requirements of the binding regulations.

The accessible, easy-to-follow guide that demystifies documentation management When it comes to receiving documentation to confirm good science, U.S. and international regulators place high demands on the healthcare industry. As a result, companies developing and manufacturing therapeutic products must implement a strategy that allows them to properly manage their records and documents, since they must comply with rigorous standards and be available for regulatory review or inspection at a moment’s notice.Written in a user-friendly Q&A style for quick reference, Managing the Documentation Maze provides answers to 750 questions the authors encounter frequently in their roles as consultants and trainers. In simple terms, this handy guide breaks down the key components that facilitate successful document management, and shows why it needs to be a core discipline in the industry with information on: Compliance with regulations in pharmaceutical, biological, and device record keepingElectronic systems, hybrid systems, and the entire scope of documentation that companies must manageHow to write and edit documents that meet regulatory complianceMaking the transition to an electronic system, including how to validate and document the processAnyone responsible for managing documents in the health field will find this book to be a trusted partner in unraveling the bureaucratic web of confusion, while it initiates a plan on how to put an effective, lasting system in place—one that will stand up to any type of scrutiny.

The current revolution in software, and the regulations that have evolved to address it, have increasingly caused companies to turn to off-the-shelf software for electronic record keeping. Data captured in computerized systems must be as reliable, if not more so, than data on paper. Electronic Record Keeping: Achieving Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 explores how to evaluate, select, implement, and document an e-system that will keep your organization in compliance.Covering Title 21 of the Code of Federal Regulations (CFR) Part 11 and the parallel, recently passed Title 45 CFR Parts 160, 162, and 164 of the Health Insurance Portability and Accountability Act (HIPAA), this book provides guidance for selecting, purchasing, installing, validating, and managing commercial off-the-shelf software for data collection and retention. It takes a number of years for industry standards for a new regulation to develop from dialog between companies and the regulating agency. These standards are in place for Part 11, which was passed into law in 1997. Healthcare providers who must implement electronic record keeping can learn how to best do it by understanding the parallel between the new HIPAA regulations and the industry standards for Part 11. Further, certain FDA-driven activities, such as patient record keeping in clinical trials, now must comply with the new HIPAA regs as well. To help companies achieve and maintain compliance, the authors cover audit trails, validation, documentation, training, and security and accountability. They discuss what the regulations say and what they mean.Compliance may be mandatory, but it also makes good business sense. Companies that are compliant will always be poised to move forward, and they will avoid the grief that comes from poor or faulty record keeping and documentation. This book gives you the tools you need to keep your company both compliant and competitive.

A well-understood tenet exists among the FDA and other regulatory bodies: if you didn't write it down, it didn't happen. And if it didn't happen, your company stands to lose time, money, and perhaps its competitive edge. Write it Down: Guidance for Preparing Effective and Compliant Documentation provides you with the tools you need to put effective documentation in place. The book has a three-pronged focus: to help writers understand the why of what they must write and the current industry standards for good documentation practices, to provide effective examples of a broad spectrum of documents, and to supply an in-depth explanation of grammar and punctuation conventions.Substantially expanded, the second edition focuses on the regulations, the need to document, and the range of documentation that must be in place to support therapeutic products from discovery through market. Readers will find useful examples of good writing, many provided by people in the industry. Letters and memos; short reports of varied topics, including equipment evaluation, vendor audit, and trip review; standard operating procedures, laboratory methods, and training materials; documentation for an IQ/OQ/PQ project; a journal article; and excerpts from a development report and a dossier are among the many examples. The book also gives a thorough explanation of grammar, punctuation, and usage, with a strong emphasis on the components of the language that pose difficulties for non-native writers of English.This book is a must for people working in or preparing to work in environments that produce drugs, medical devices, or biologics for sale in countries that have stringent regulatory requirements and where the business language is English. Firmly placing the writing task in context of the existing laws and guidances, the book offers valuable insights into managing systems and producing documentation that meets the requirements of the binding regulations.

Fascinating illustrated survey of England's churches in all their variety -- one from every diocese in the country. For centuries church buildings have defined the English landscape and acted as landmarks by land and sea. First and foremost places of worship and mission, they have often been used by the wider community, preserving local stories. But they have also been integral to the country’s history, telling the story of Christianity in England as well as marking significant events from our past. The churches featured in this beautifully illustrated volume have been drawn from each of the Church of England's 42 dioceses to showcase their varied architecture, art and uses. They are all extraordinary buildings and many of them contain exceptional treasures. This book pays tribute not only to the exquisite architectural and artistic heritage of our nation, but also to the remarkable unsung heroes of our church buildings: the clergy and the many volunteers who keep them open and sustainable. We hope it will encourage many more to visit, enjoy and support the Church of England’s unique heritage of nearly 16,000 church buildings.

"Curiously few people think of Britain’s cathedrals as being among our most impressive museums. This book should change that." — The TelegraphThe cathedrals of England and Wales are remarkable buildings. From the centuries leading up to the Norman Conquest to the tumults of the Reformation to the devastating wars of the 20th century, they carry traces of our nations’ darkest moments and most brilliant endeavours.This beautifully illustrated new volume tells the stories behind 50 remarkable artefacts – one for each cathedral – that have been preserved by the cathedrals of the Church of England and the Church in Wales.Featuring the Magna Carta of Salisbury Cathedral as well as the oldest book of English literature in the world, an Anglo-Saxon portable sundial, and Pre-Raphaelite glass, painting and embroidery, these local and national treasures are a vital part of our heritage, testifying to the powerful and enduring links between cathedrals and the wider communities of which they are part.

"...packed with superb colour photographs... This book is a wonderful companion to cathedral-crawling, not least in helping the crawlers work out what is, and what isn't, worth seeing" - Simon Heffer, Telegraph"A beautifully illustrated guide" — Premier Christianity“[The] thrilling tale of the medium’s continuity… is set forth by Janet Gough, the erstwhile director of Cathedrals and Church buildings at the C of E, in her latest book, Divine Light” — World of Interiors"I would recommend that you visit some of these cathedrals, book in hand." — The Methodist RecorderThe stained-glass windows of England’s cathedrals illuminate interior spaces, communicate religious and other messages, and – perhaps – offer us a glimpse of heaven. This book tells the remarkable story of these much-loved works of art.Divine Light features glass from every Church of England cathedral. It spans 900 years, beginning with the windows installed at Canterbury Cathedral following the murder of Thomas Becket in 1170 and representing every subsequent century in the history of English stained glass. Divine Light encompasses the Middle Ages, the Reformation, the hugely productive ‘long 19th century’, the Pre-Raphaelites, the Arts and Crafts movement, the creative commissions of the 20th century, and the innovative glass being commissioned by cathedrals today.The book establishes the connections between the artistic beauty of stained glass, its effectiveness as a narrative medium, and the various technical developments that have shaped the work of practitioners over the centuries. The refraction of light through coloured glass emerges as an early form of mass communications that retains its power to move and inspire today.