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Process Optimization and Control in the context of PAT

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You want to organize your production according GMP-standards or you fullfill them already ? In addition, you want to understand or control your processes much better ? PAT (Process Analytical Technology) is a systematic approach which got a central point in the "GMP initiative for the 21. century" of the FDA and is also strong supported by the EMEA.


What would you learn ?
The process control requried in the context of PAT causes to huge amount of data. In this course you will learn to design, analyse and watch systematicly production processes, based on measurements of the critical parameters. Our main focus will be the methods, which result in a better understanding of processes if used right. The applications will be illustrated through examples from practice and supplemented with demonstrations of software. In addition, you will have the possibility to apply directly your knowlege by doing many exercises on PC.

Who should attend ?
  • Scientists, engineers and quality managers in Development, Production or Quality Assurance
  • Elementary statistical knowledge is assumed (as given in the course "Visualization of Lab Data" )

Which topics are covered ?
 The PAT concept
 The philosophy of PAT
Strategies of process enhancement
 Basics
 Visualization of data
Linear Regression: modelling the structure of correlation between two observations
 Statistical design of experiments
 Concepts of statistical design of experiments
User defaults
Strategy:
  • Screening
  • Modeling
  • Optimization
Experimental designs:
  • Factorial designs
  • Fractional designs
  • Designs for optimization
Analysis and interpretation of results 
 Statistical process control
 Quality Control Cards
Cusum Cards
Process capability indices Cp and Cpk
 Multivariate analysis
 Principal Components Analysis (PCA)
Discriminant analysis
Application: reduction of dimensions and multivariate process control


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