9798284800621 - qc labs: a practical guide for analytical methods: 6 di gorjanu, mirela (9 risultati)
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Paperback. Condizione: new. Paperback. QC Labs: A Practical Guide for Analytical MethodsAuthor: Mirela Gorjanu, MScYour blueprint for mastering pharmaceutical quality control.In a world where regulatory scrutiny, data integrity, and patient safety define success, QC Labs: A Practical Guide for Analytical Methods is the trusted c…ompanion every pharmaceutical professional needs.This comprehensive and deeply practical guide walks you through the full spectrum of quality control operations from foundational lab setup and instrument qualification to advanced method validation, risk-based decision-making, and regulatory inspection readiness. Whether you're a QC analyst, QA specialist, regulatory affairs professional, or laboratory manager, this book is your essential toolkit.Inside, you'll find: Step-by-step instructions for HPLC, GC, spectroscopy, titration, and microbiological testing ICH, FDA, and EMA-compliant method validation frameworks Real-world case studies, audit checklists, and troubleshooting references Sample SOPs, data integrity principles, and ALCOA+ best practices Emerging technologies: LIMS, PAT, automation, AI, and real-time release strategiesWritten in clear, accessible language by pharmaceutical chemist Mirela Gorjanu, this book bridges theory and execution, empowering professionals to meet the highest standards of compliance and lab excellence. This item is printed on demand. Shipping may be from multiple locations in the US or from the UK, depending on stock availability.
Lingua: Inglese
Editore: Independently published, 2025
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Da: California Books, Miami, FL, U.S.A.California Books
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Paperback. Condizione: new. Paperback. QC Labs: A Practical Guide for Analytical MethodsAuthor: Mirela Gorjanu, MScYour blueprint for mastering pharmaceutical quality control.In a world where regulatory scrutiny, data integrity, and patient safety define success, QC Labs: A Practical Guide for Analytical Methods is the trusted c…ompanion every pharmaceutical professional needs.This comprehensive and deeply practical guide walks you through the full spectrum of quality control operations from foundational lab setup and instrument qualification to advanced method validation, risk-based decision-making, and regulatory inspection readiness. Whether you're a QC analyst, QA specialist, regulatory affairs professional, or laboratory manager, this book is your essential toolkit.Inside, you'll find: Step-by-step instructions for HPLC, GC, spectroscopy, titration, and microbiological testing ICH, FDA, and EMA-compliant method validation frameworks Real-world case studies, audit checklists, and troubleshooting references Sample SOPs, data integrity principles, and ALCOA+ best practices Emerging technologies: LIMS, PAT, automation, AI, and real-time release strategiesWritten in clear, accessible language by pharmaceutical chemist Mirela Gorjanu, this book bridges theory and execution, empowering professionals to meet the highest standards of compliance and lab excellence. This item is printed on demand. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability.
