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Serving Pharmaceutical, Medical Device, and Biotechnology Industries

RCA6425 Fundamentals of Process Analytical Technology (2 days)

  

Process Analytical Technology (PAT) is an emerging operations strategy that can significantly improve the
following:

  • Reduce manufacturing cycle times and fast track production throughput
  • On line, real time quality control
  • Reduce laboratory quality control overheads
  • Improve process knowledge and efficiency
  • Streamline and cut validation programs
  • Reduce warehouse inventory.

PAT, together with statistical process control tools, has the potential to create a paradigm shift in the way
industry manages and controls the quality of products.

This training program will provide participants with an introduction to Process Analytical Technology (PAT), its application in the current pharmaceutical industry, and data analysis obtained from process analyzers, and to develop a broad understanding of the new process analysis, and control technologies.

Topics include but are not restricted to:
  • PAT Business Aspects
  • Risk Assessment Related to PAT
  • Process Analyzers
  • Statistical Data Analysis related to PAT
  • NIR as a PAT Tool
  • Implementation and Validation

Learning Outcomes

After completion of this course, the participant will be able to:

  • Prepare Process Maps to isolate critical control points where PAT analyzers would provide the most benefit to process understanding.
  • Apply risk assessment to process analytics outlining the benefits of technology implementation.
  • Present effective business cases for justifying the use of PAT systems.
  • Application of the correct PAT technology and data handling system for the process under investigation.
  • Apply Basic Statistics and Chemometrics to process data.

Who Should Attend

This course is ideal for people working in process improvement initiatives or using rapid spectroscopic tools for process control. It is assumed that you will already have a degree in chemistry, applied statistics, physics or chemistry