This two-day course will focus firstly on the development of suitable analytical methods for the detection of cleaning residues and secondly on the systematic validation of these methods.

Programme

• Introduction
• Cleaning method characteristics
• Sampling techniques of cleaning residues
• Calculation of allowable carryover (MAC)
• Workshop
• Specificity of measurement method
• Accuracy (incl. exercises with Excel)
• Precision of measurement method (incl. exercises with Excel)
• Detection and quantitation limits of measurement methods (incl. exercises with Excel)
• Linearity of measurement method (incl. exercises with Excel)
• Range
• Robustness
• Documentation of method validation