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.
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