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
| HOME | Software | Courses | Books | Consulting | Ordering | Contact |