The Pharmaceutical and GMP Dictionary, Cooper Brendan
Автор: Cooper, Brendan Название: William blake`s songs of innocence and of experience ISBN: 1787072207 ISBN-13(EAN): 9781787072206 Издательство: Peter Lang Рейтинг: Цена: 4063.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
William Blake (1757-1827) is one of the most significant figures in the history of English poetry. He is also one of the most mysterious, most challenging, and most frequently misunderstood. His Songs of Innocence and of Experience, on the surface so simple, are laden with mysteries that seem to deepen on every reading.
In this book, aimed at A Level and undergraduate students, Brendan Cooper explores the subtleties and contradictions of the Songs, avoiding formulaic readings by asking key questions about Blake's life and art. What are the Songs about? What does Blake mean by Innocence and Experience ? Why are they called Songs ? Was Blake a genius, or a madman?
This engaging and accessible introduction to Blake's work will help students to navigate its complexities and develop their own critical responses to the text.
Автор: Cooper Brendan Название: GMP Audit Trainer: Good Manufacturing Practices Made Easy ISBN: 1548711934 ISBN-13(EAN): 9781548711931 Издательство: Неизвестно Цена: 6033.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Both internal and external GMP audits/inspections are a key requirement of Quality Management systems across medical device, biotechnology and pharmaceutical industries. Achieving a successful audit outcome is essential to maintaining an effective QMS and fundamental to retaining manufacturing licenses. In order to align systems and processes to ensure compliance and favorable audit outcomes personnel must understand the auditor focus and methodologies. This book summarises key areas that inspections cover along typical areas of risk and concern. The following chapters are included: Introduction to Good Manufacturing Preparation for AuditsInspection of Quality Systems During the InspectionBiotechnology Inspection GuideMedical Device Inspection GuideDrugs Inspection Guide Computerised Systems Inspection GuideCHAPTER 8Computerised Systems Inspection GuideIntroduction94Hardware 94Validation of Hardware96Software98Electronic Records and Signatures106Electronic Records Verification Methods11
Автор: Cooper Brendan Название: The GMP Handbook: A Guide to Quality and Compliance ISBN: 1548370258 ISBN-13(EAN): 9781548370251 Издательство: Неизвестно Цена: 6033.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: CGMP, Current Good Manufacturing Practices has legal and practical implications for manufacturers of medicinal products and medical devices. The requirements to meet CGMP is legal requirement but it also ensures the patient receives products that are safe, effective and of consistent quality. The FDA, WHO, ICH, PIC/s AND Eudralex provide extensive guidance and regulations on many topics related to the manufacture of medicinal and drug products. A large body of reference materials is available to manufacturers and engineering professionals. This book brings together the key requirements of GMP and briefly examines the common themes and requirements published by the various authorities, bodies and international organisations. The book includes the following chapters: Chapter 1-Overview of Good Manufacturing Practices Chapter 2-Quality ManagementChapter 3-PersonnelChapter 4-Buildings and FacilitiesChapter 5-Process EquipmentChapter 6-Documentation and RecordsChapter 7-Materials ManagementChapter 8-Rejection and re-use of materialsChapter 9-ValidationChapter 10- Change Control Chapter 11-Complaints and recallsPage count 160. Paperback book. Large 8" x 10" format
Автор: Brendan Cooper Название: How to Write About Poetry: A Pocket Guide ISBN: 1788747283 ISBN-13(EAN): 9781788747288 Издательство: Peter Lang Рейтинг: Цена: 1715.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
When secondary school or university students are asked what they find hardest about studying English, the most popular answer by far is poetry. This book is the first poetry analysis guide intended for all candidates studying English at secondary and university levels. Importantly, it is a «pocket guide» – concise and accessible. This means that all students will be able to find it useful, whether they happen to be struggling in the subject or trying to secure their own top-grade performance. The guide is organised into five short, reader-friendly chapters: an introduction, «Why is Poetry Difficult?», «What do Poems Mean?», «The Challenge of Poetic Form», and «How to Write an Essay on a Poem». Each of these chapters challenges particular misunderstandings about poetry while presenting some clear, practical strategies for how to analyse poems.
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