Articles liés à Pharma Bioanalytical Lab: A Practical Guide

Pharma Bioanalytical Lab: A Practical Guide - Couverture souple

Livre 7 sur 58: Pharmaceutical Industry

Gorjanu, Mirela

 
9798284788868: Pharma Bioanalytical Lab: A Practical Guide
Couverture souple
ISBN 13 : 9798284788868
Editeur : Independently published, 2025

Synopsis

Pharma Bioanalytical Lab: A Practical Guide
by Mirela Gorjanu
In the high-stake world of pharmaceutical development, data integrity isn’t optional; it’s critical. Pharma Bioanalytical Lab: A Practical Guide is the definitive handbook for scientists, analysts, and quality professionals working in regulated bioanalytical environments. Whether you're managing GLP-compliant studies, preparing for regulatory audits, or validating LC-MS/MS methods, this guide delivers practical, real-world strategies to ensure accuracy, compliance, and efficiency.
Written by experienced pharma chemist Mirela Gorjanu, this resource bridges theory and execution with:

  • Step-by-step instructions for method development, validation, and documentation
  • Templates and SOP outlines for daily lab operations
  • Tools for deviation management, CAPAs, and analytical risk assessments
  • Regulatory insights from FDA, EMA, WHO, and ICH M10 standards
  • Visual aids, glossary terms, and case studies that simplify complex concepts
Whether you're setting up a new lab or optimizing an established one, this guide will help you build systems that are not just audit-ready but inspection-proof.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

Éditeur
Independently published
Date d'édition
2025
Langue
anglais
ISBN 13 
9798284788868
Reliure
Broché
Nombre de pages
100
Coordonnées du fabricant
Manufactured by Amazon on behalf of the author
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