Process monitoring, control, and improvement has been at the heart of quality management for decades. The methodology continues to develop and has moved into a new era with the widespread availability of online data collection systems. 

This presentation discusses several recent advances, such as FDA’s 2011 Process Validation Guidance calling for “Continued Process Verification” (CPV). Process monitoring provides the tools for enabling CPV and dealing with variation.  Clearly stated in the guidance is the need to understand, detect, control, and reduce variation. 

This session addresses how tools are integrated to create a data-based system to  enhance the use and effectiveness of tools for continued process monitoring, control and improvement. The approach is illustrated with a variety of case studies including pharmaceuticals. 

What you can expect to learn:

  • Implementation of FDA Validation Guidance regarding Continued Process Verification (CPV)
  • How to integrate statistical tools into a system for process monitoring, control and improvement (CPV)
  • Process Control Strategy – Integrating use of process Stability and Capability Metrics
  • How to reduce process risk and method risk
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