🎤  Dr. John C. Fetzer     |  📅  Recording Available   |  🕒  60 Minutes


Compliance under GLP can be difficult. The setting up of a system to monitor the performance of methods and instruments can lessen this. Statistical Process Control (SPC) uses control charts and statistical guidelines to monitor a wide variety of things in the compliant laboratory. These generate a proactive system to assess problems early on and quickly to be handled by adjustments rather than the strict situation of a non-compliance event.

Control charts are based on the distribution of data expected in a laboratory, the Gaussian distribution of occurrences. There are well-defined probabilities for the data. Guidelines for good or unacceptable behavior are well known. The most common of these are Nelson Rules, in use for over a century. With a wide selection of variables to monitor, assessing performance can be simple. 

Areas Covered in the Session:

  • Control charts and their underlying statistics
  • Choosing variables to monitor
  • Maintaining the records
  • Planning adjustments
  • Examples and walk through of control chart implementation and use
  • Review of the relevant statistics

Who Should Attend:

  • Lab Chemists
  • Lab Managers
  • Lab Technicians
  • Lab Analysts
  • Industries into Compliance Methodology (Biotech, Pharma)
  • Quality Personnel
  • Manufacturing Personnel
  • Operations/Production Managers
  • Production Supervisors
  • Supplier Quality personnel
  • Quality Engineering 
  • Quality Assurance Managers, Engineers
  • Process or Manufacturing Engineers or Managers

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