Comprehensive QRM model overview: Provides a thorough understanding of the Q9 R1 risk management framework for pharmaceutical and biopharmaceutical settings
Step-by-step risk assessment methods: Describes multiple tools and techniques, including FMEA and risk check sheets, for effective risk identification and evaluation
Focus on risk-based decision making: Emphasizes the importance of bias reduction and risk-based thinking in decision processes
Facilitation and program evaluation chapters: Offers guidance on conducting risk assessments and evaluating risk management programs
Case studies and real-world examples: Illustrates practical application of QRM concepts in diverse pharmaceutical and healthcare environments
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by James Vesper and Amanda McFarland ISBN: 978-1-917195-12-6 ebook £195 ISBN: 978-1-917195-13-3 Hardback £225
Since the publication of the first Quality Risk Management (ICH Q9) guideline in 2005 and the Risk Assessment and Risk Management in the Pharmaceutical Industry book by James Vesper in 2006, the pharmaceutical industry has mad