Essential Elements for a GMP Analytical Chemistry Department

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Essential Elements for a GMP Analytical Chemistry Department identifies the essential elements required for a successful GMP Analytical Department to function as an efficient and effective organization. It describes in detail a department structure which allows for the necessary processes to become...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Catalano, Thomas (Autor)
Autor Corporativo: SpringerLink (Online service)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: New York, NY : Springer New York : Imprint: Springer, 2013.
Edición:1st ed. 2013.
Temas:
Pharmaceutical chemistry.
Pharmaceutics.
Acceso en línea:Texto Completo
Tabla de Contenidos:
  • Introduction
  • Organization
  • Department Structure
  • Project Teams
  • Responsibilities
  • Interactions
  • Operating Guidance's
  • Processes
  • Safety
  • Technology
  • Department
  • Statistical Concepts for the Analytical Chemist
  • Data distribution
  • Significance Testing
  • Confidence Intervals
  • Outliers in analytical data
  • Regression
  • Experimental design
  • Required sample replicates
  • Method performance
  • Uncertainty measurement
  • Sampling strategies
  • Outsourcing
  • Process
  • Audit Check List
  • Documentation
  • Sample Submission
  • Technical Report
  • Reports of analysis
  • Records (Training etc.)
  • Job Descriptions
  • Career Tracks
  • Motivating Personnel
  • Career Path
  • Hiring the Best.

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