This handbook details methods for sustainable compliance with GxPs and 21 CFR Part 11 validation requirements regarding computerized systems in the pharmaceutical, biotechnology, and medical device industry. The handbook follows FDA guidelines and best industry practices in defining roles, responsib

The descriptions of the author's young life growing up in the late 1940's and early to mid-1950's in various parts of Philadelphia will keep readers attention and bring to light some of the happenings particular to that era and place. Goldman depicts his early youth detailing the locale, his homes and surroundings, as well as some of his encounters - some whimsical, some serious. He provides impressions of an independent mind making observations of his surroundings and events as a boy.