Statistical Process Control (SPC) and Control Charts for Laboratory Compliance

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

Course Director: DR. JOHN C. FETZER

Dr. John C. Fetzer has been doing liquid chromatographic method development for over 35 years. His PhD was in studies of various types of chromatography. He has authored or co-authored over 50 papers on LC separations, has served on the advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry. He supervised the Good Laboratory Practices accreditation of a large research chromatography laboratory and has taught numerous short courses on GLP and ISO 17025 compliance.