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Title:
Quality risk management in the FDA-regulated industry / José Rodríguez Pérez.
Call Number:
615.1068 ROD
Publication Date:
c2012.
Publisher:
Milwaukee, Wis. : ASQ Quality Press, c2012.
Physical Description:
xix, 264 p. ; 23 cm. + 1 CD-ROM (4 3/4 in.).
Contents:
Preface -- Acknowledgments -- Introduction to quality risk management -- Current initiatives -- Principles of quality risk management -- General quality risk management process -- Integration of risk management with quality management -- Methodologies and tools -- Practical applications of quality risk management to the life science manufacturing industry -- Appendix A: General examples -- Appendix B: Case studies -- Appendix C: "Fail-safe FMEA" / by José Rodríguez Pérez and Manuel E. Pea-Rodriguez.
Bibliography Note:
Includes bibliographical references and index.
Horizon Bib Number:
1429124
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