Alan Kusinitz, Managing Partner of SoftwareCPR, chaired the Production Software Validation sessions of the 1998 HIMA Software Conference. The attached pdf file is a transcript of his talk “Validating Manufacturing Process Software: Regulatory Issues” and a transcript of the Q&A session for all of the talks on this topic. During the Q&A there is some informative discussion with Steward Crumpler of FDA on several issues including validation of compilers.