Essential Elements for a GMP Analytical Chemistry Department
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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| Format: | eBook |
| Language: | English |
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New York, NY
Springer New York
2013, 2013
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| Edition: | 1st ed. 2013 |
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| Online Access: | |
| Collection: | Springer eBooks 2005- - Collection details see MPG.ReNa |
Table of Contents:
- 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