<p>This new book provides a truly global perspective on data integrity and the solutions available to address this serious issue. It includes two main sections: the regulatory and historic background of data integrity, and practical advice on how to prevent or rectify data integrity breaches. Each chapter is written by renowned, highly experience subject matter experts in the fields of compliance and data integrity, and includes a "how to" section with practical, implementable advice. Content is up to date with the latest regulations and guidances, making this the most relevant reference source of its kind. Useful checklists and aide memoirs can be customized by the discerning reader. This book should be equally useful for the quality unit professional, operations manager, validation experts and regulators. The modular structure allows readers to pick chapters of special interest without having to reach the chapters in order. However, given the usefulness and universal application the "nuggets of wisdom" and advice provided, it is anticipated that readers will want to read the publication in its entirety.</p>

Assuring Data Integrity for Life Sciences

Siegfried Schmitt

Reference

PDA/DHI

<p>Following an introduction to the subject of Good Distribution Practice (GDP), the first volume of this book covers key topics related to five main points: the applicable GDP regulations worldwide, including serialization; an overview of the requirements of Qualified Persons and Responsible Persons in GDP; GDP as part of the Quality Management System; an industry perspective on GDP; and a practical GDP checklist.</p>

Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 1

pdatechnicalbooks

Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 2

Fundamentals of Pharmaceutical and Biologics Regulations A Global Perspective

Regulatory Affairs Professionals Society

Linda McBride

Regulatory Affairs Professionals Society (RAPS)

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Books by Siegfried Schmitt