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Process Analytical Technology 
Training Program

A training program was established for the PATRIOT (PAT Review, Inspection and OPS (Office of Pharmaceutical Science) Policy Development Team) members who will manage the review/inspection process. This program was developed in coordination with several academic centers of excellence and includes didactic sessions, as well as advanced on-site practicums.
  • Ken Morris; Purdue University, Monday, December 16, 2002.
    Overview of Pharmaceutical Unit Operations
    • Overview of Pharmaceutical Unit Operations 
    • Particle Size Reduction
    • Mixing                  
    • Flow and Blending
    • Granulation
    • Introduction to Drying Basics
    • Tablet Compression
    • Fundamental Factors in Film Coating

  • Paul Gemperline; East Carolina University, MCEC, Monday, December 16, 2002.

    • Introduction to Chemometrics

    • Review of  Basic Statistics and Linear Algebra
    • The Multivariate Normal Distribution: Introduction to Pattern Recognition

  • Paul Gemperline; East Carolina University, MCEC, Tuesday, December 17, 2002.

    • Introduction to Principal Component Analysis

    • Introduction to Multivariate Calibration

  • Brian Marquardt; University of Washington, CPAC, Tuesday, December 17, 2002. Measurement Techniques
    • FDA-PAT Spectroscopy Training: Raman Spectroscopy                  
    • PAT Training Course: FTIR Process Monitoring
    • PAT Training Course: Light Scattering
    • PAT Training Course: Chemical Imaging

  • Ken Morris; Purdue University, Tuesday, December 17, 2002.
    • Near Infrared Spectroscopy Basics

  • Mike McCarthy; University of California, Davis, CPAC, Tuesday, December 17, 2002.
    Measurement Techniques
    • Ultrasonic Measurements for Process Characterization 
    • Use of Nuclear Magnetic Resonance for Sample and Resonance Characterization

  • Steve Byrn; Purdue University, Wednesday, December 18, 2002.
    Analytical Chemistry of Solids: Measurement Systems for Solids
    • Analytical Chemistry of Solids: Measurement Systems for Solids
    • Crystallography
    • X-Ray Powder Diffraction
    • Spectroscopic Techniques
    • Chemical Imaging 
    • Particle Size
    • Mixture Analysis            
    • Technologies for PAT
    • Blending Related Studies: Monitoring at the Tablet Press
    • Sensors for Crystallization

  • Mel Koch; University of Washington, CPAC, Wednesday, December 18, 2002.
    Chemical Separations and Related Techniques
    • Process Analytical Technologies: Chemical Separations and Related Techniques 
    • Data Analysis: A Historical Perspective

  • Charlie Moore; The University of Tennessee, MCEC, Thursday, December 19, 2002.
    • Process Control Overview

  • Rick E. Cooley; Eli Lilly and Co. University of Michigan Pharmaceutical Engineering Seminars, March 4, 2003.

    • Utilizing PAT to Monitor and Control Bulk Biotech Processes

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FDA/Center for Drug Evaluation and Research
Created: April 23, 2003
Originator: OTCOM/DLIS
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