Essential Elements for a GMP Analytical Chemistry Department

• Κύριος συγγραφέας: Catalano, Thomas (Συγγραφέας)
• Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
• Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: New York, NY : Springer New York : Imprint: Springer, 2013.
• Θέματα: Medicine.; Pharmaceutical technology.; Biomedicine.; Pharmaceutical Sciences/Technology.

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...

Πίνακας περιεχομένων:

• 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.