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
- 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
FDB3466
