EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

Author: Orlando Lopez

Publisher: CRC Press

Published: 2015-04-06

Total Pages: 372

ISBN-13: 1482243636

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Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems.The purpose of Annex 11 is


Model Rules of Professional Conduct

Model Rules of Professional Conduct

Author: American Bar Association. House of Delegates

Publisher: American Bar Association

Published: 2007

Total Pages: 216

ISBN-13: 9781590318737

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The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.


GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 1 - With Checklists and Software Package)

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 1 - With Checklists and Software Package)

Author: Leonard Steinborn

Publisher: CRC Press

Published: 2019-04-23

Total Pages: 633

ISBN-13: 0429525826

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Volume 1 of this two-part package provides a complete set of checklists for internal and contract device and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed material, electronic component, and general supplies. It also includes a simulated QSIT audit, and a new-product market launch. All of these


The Doctor's Handbook

The Doctor's Handbook

Author: Tony White

Publisher: CRC Press

Published: 2018-04-19

Total Pages: 337

ISBN-13: 1315346397

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Many doctors do not receive training early in their careers on the broad range of non-clinical aspects of their work, and confront day-to-day issues for which initial medical education has failed to prepare them. Experienced doctors and consultants can also experience a similar lack of accessible reference material on these aspects of their role and for the non-clinical training of their juniors. This book and its companion volume The Doctor's Handbook Part 1: managing your role beyond clinical medicine, have been written to address these and other needs. Previously published as The Specialist Registrar and New Consultant Handbook, these completely revised and reconfigured volumes reflect the changing everyday work of specialist trainees, registrars and consultants. Topics covered in Volume 2 include: *


A Guide to the NHS

A Guide to the NHS

Author: Tony White

Publisher: CRC Press

Published: 2018-05-08

Total Pages: 198

ISBN-13: 1315357615

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To maximise the effectiveness of their work, NHS employees need a clear understanding of the structures and systems of the organisation in which they work. However, this information can be widely spread, hard to access and difficult to gain a working overview of, and the pace of changes and initiatives can seem almost dizzying. This book draws together a clear picture of the modern NHS, from funding and governance to reports, inquiries and overarching legislation. The book is clear and easy to understand and crucially includes full references to provide a one-stop point of access to the most detailed and up-to-date information available. This book is essential reading for workers in the NHS at all levels, including managers, administrators and clinical professionals. It is vital reading for managers and staff at commercial companies working with the NHS. It will also be of interest to campaigners, patient interest groups, researchers and journalists with an interest in the NHS. Specialty registrars and consultants can also find the information from the book, and much more, in The Doctor's Handbook Parts 1 & 2, by the same author. 'Rather than long narrative histories or complex explanations, the author signposts readers to sources of further information, making this book the quick guide so many of us need' - from the Foreword by Sir Ian Carruthers


Preparing for FDA Pre-Approval Inspections

Preparing for FDA Pre-Approval Inspections

Author: Martin D. Hynes

Publisher: CRC Press

Published: 2016-04-19

Total Pages: 310

ISBN-13: 1000654370

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This Second Edition is an essential guide to preparing for FDA pre-approval inspections-taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. Th