PAT - 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