Quality risk management in the FDA-regulated industry / José Rodríguez-Pérez.
| Author/creator | Rodríguez Pérez, José, 1961 |
| Format | Electronic |
| Edition | Third edition. |
| Publication Info | Milwaukee, Wisconsin : Quality Press, 2024. |
| Description | xv, 295 pages illustrations 23 cm |
| Supplemental Content | Full text available from Ebook Central - Academic Complete |
| Subjects |
| Physical medium | illustrations |
| Abstract | "Risk-based thinking and processes are increasingly important for all organizations, including those regulated by the FDA. This book is an essential guide to a systematic and comprehensive approach to quality risk management. The revised content in this third edition offers an updated view of the risk management field as it applies to FDA-regulated products: how to integrate risk management principles and activities into an existing QMS, remain in compliance with ISO 9001:2015 and ISO 13485:2016, and integrate three key and recently updated guidelines [ICH Q9(R1), ISO 14971:2019, and ISO 22000:2018]. Also includes practical explanations and plenty of helpful case studies and examples"-- Provided by publisher. |
| General note | Previous edition: 2017. |
| Bibliography note | Includes bibliographical references (pages 291-295) |
| Access restriction | Available only to authorized users. |
| Technical details | Mode of access: World Wide Web |
| Genre/form | Electronic books. |
| LCCN | 2024934687 |
| ISBN | 9781636941554 paperback |
| ISBN | |
| ISBN | epub |
Availability
| Library | Location | Call Number | Status | Item Actions |
|---|---|---|---|---|
| Electronic Resources | Access Content Online | ✔ Available |