Proposed Process Analytical Technology Curriculum

for FDA Inspectors and Reviewers

  1. Basic Statistics
    1. Nature of Randomness
    2. Analysis of Variance
    3. Permutation of Error
    4. Figures of Merit: Precision, accuracy, limit of detection, dynamic range, sensitivity
  2. Measurement Systems
    1. Figures of Merit: Robustness (interferences), speed, hysteresis, maintenance, reliability, (self) diagnostics, etc.
    2. Continuous vs discrete
    3. Sensors: Temperature, pressure, flow, etc.
    4. Physical properties: density, viscosity, particle size, rheology, etc.
    5. Process Analysis:
      1. Electrochemical
      2. Absorption spectrometry and optical sensors
      3. Advanced spectrometry
    6. Sampling systems
    7. Sensor placement
  3. Data Analysis
    1. Dimensionality
    2. Correlation and Regression
    3. Chemometrics
    4. Pattern Recognition
    5. Database design and mining
  4. Process Control
    1. Automation vs Statistical Control
    2. Statistical Process Control
      1. Statistical Sampling
      2. Attribute Charts
      3. Moving Range and Individuals Charts
      4. Components of Variation
      5. Design of Experiments
      6. Process Capability
    3. Batch Automation
      1. Recipe management
      2. Within batch control
      3. Batch-to-batch control
      4. Characterization of batch trajectories and end points
      5. Scheduling
    4. Continuous Control
      1. Feedback
      2. Feed forward
      3. Cascade
    5. Model-based control
    6. Control Implementation
      1. DCS
      2. PLC
      3. Database Historians
  5. Pharmaceutical chemical processing fundamentals:
    1. Reaction
    2. Separation/Crystallization
    3. Mixing
    4. Storage
    5. Transport
    6. Grinding/Solids Handling
    7. Dissolution
    8. Packaging