PAT- Pharmaceutical Applications of NIR

What You Will Learn
Significance of FDA's PAT Initiative
How to exploit NIR for process monitoring and control
Advantages and disadvantages of different instruments and sampling systems
How to produce effective calibrations
How to choose appropriate software
Essential elements for successful projects

Who Should Attend
Chemists, statisticians, process engineers, who wish to learn how to work within the FDA's PAT Initiative to beneficially exploit the powerful capabilities of NIR analysis for process monitoring and control, QA, and QC. Managers who wish to understand how to successfully apply NIR to increase throughput, improve quality, enhance productivity, reduce risk, and increase profitability. Prior use or knowledge of NIR methods is not required.

Topics

DAY 1:
Introduction to PAT
Rationale
History
Regulatory Overview
   FDA, USP, EMEA, ICH, ASTM
Present status of PAT
Introduction to near infrared analysis
Spectral region
Analytical advantages and disadvantages
Materials
Measurement modes
Standards and resources
Particle size measurement
Analysis without calibration
Sucrose
NIR Instrumentation
Generic instrument designs
Technologies and components
Accessories
Fiber optics
New Technologies
Introduction to chemometrics for PAT
Data analysis and probability
Statistical Quality Control
Design of Experiments
NIR calibration
MLR, Multiple Linear Regression
PCA, Principal Component Analysis
PLS, Partial Least Squares regression
Data pretreatments
Overview of applications
Moisture in Fluid bed dryer
Bioreaction monitoring
Powder blend monitoring
Moisture
Assay
Crystalline & polymorphic forms
Fill Weight
Off-the-press Tablet Analyzer

DAY 2:
NIR software
Instrument manufacturers
Third party software
Statistical analysis software
Qualitative Analysis
Visual comparison of spectra
Multiwavelength methods
Mahalanobis Distances
Polar Qualification System
Spectral Match Index
Conformity Index
Case studies - Qualitative Methods
Clinical Trials - disposable calibrations
Imaging
Product uniformity
Method validation
Definitions of "validation"
Repeatability
Precision and accuracy
Specificity
Robustness
Treatment of results
Case studies selected from:
Raw material inspection
Excipients
Solvents
Packaging
Optical isomers
Crystalinity and polymorphs
Counterfeit products


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