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 :
Who Should Attend: