Kirjahaku

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.

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.

"Curiously few people think of Britain’s cathedrals as being among our most impressive museums. This book should change that." — The Telegraph ?The 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.

The 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 nearly 850 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.

A cathedral is the mother church of a diocese, the seat of a bishop. Together, the 42 English cathedrals of the Church of England constitute one of the world's great achievements in architecture. They are an artistic embodiment of the spiritual sublime as well as a unique record of the history of England. They include the great medieval cathedrals of Canterbury, Winchester, Durham and Ely, which were supported by monastic communities, and the medieval secular glories of Lincoln, Salisbury, Exeter and York Minster. Later, in the wake of the dissolution of the monasteries, Henry VIII was inspired to create several new cathedrals including those at Peterborough, Oxford and Gloucester. In the nineteenth and twentieth centuries, the demands of population growth led to the enlargement and upgrading to cathedral status of a number of fine churches such as Manchester, Birmingham and Southwark, and the building of innovative new cathedrals including Liverpool and Guildford. The destruction of war caused a new cathedral to be built at Coventry. The Cathedral and Church Buildings Division of the Church of England is responsible for national policy on this extraordinary collective heritage.

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.