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