Overview of pharmaceutical product development and its associated quality system / Chung Chow Chan and Eric Jensen -- Potency method validation / Chung Chow Chan -- Method validation for HPLC analysis of related substances in pharmaceutical drug products / Y.C. Lee -- Dissolution method validation / Chung Chow Chan ... [et al.] -- Development and validation of automated methods / Chantal Incledon and Herman Lam -- Analysis of pharmaceutical inactive ingredients / Xue-Ming Zhang -- Validation study of JP heavy metal limit test / Yoshiki Nishiyama -- Bioanalytical method validation / Fabio Garofolo -- Procurement, qualification and calibration of laboratory instruments: an overview / Herman Lam -- Performance verification of UV-Vis spectrophotometers / Herman Lam -- Performance verification of HPLC / Herman Lam -- Operational qualification of a capillary electrophoresis instrument / Nicole E. Baryla -- LC-MS instrument calibration / Fabio Garofolo -- Karl Fisher apparatus and its performance verification / Rick Jairam, Robert Metcalfe, and Yu-Hong Tse -- The pH meter and its performance verification / Yu-Hong Tse, Rick Jairam, and Robert Metcalfe -- Qualification of environmental chambers / Gilman Wong and Herman Lam -- Equipment qualification and computer system validation / Ludwig Huber -- Validation of excel spreadsheet / Heiko Brunner.