96061 Computer Systems Validation Principles and Practices6cp; standard mode: 3hpw (workshop, on campus ); distance mode: fully online
Requisite(s): 96057 GMP for Manufacturing Operations AND 96134 Validation Principles and Practices AND 96059 International GMPs and Quality Assurance AND 96060 Good (Quality Control) Laboratory Practices AND 96069 Contamination Control AND 96062 Good Aseptic Practices and Sterile Products AND 96063 GxP and Quality Auditing Practices AND 96064 Risk Management for Pharmaceutical Operations
There are course requisites for this subject. See access conditions.
Information technology is a rapidly evolving field, and the development processes for information technologies are shifting equally fast. In this subject students review Computer System Validation (CSV) methodologies for changing environments, and navigate through guidance and current industry best-practices related to Good Automated Manufacturing Practices (GAMP). Students examine all stages of the software development lifecycle, including electronic records, electronic signatures, current regulatory requirements, and computer systems validation documentation and testing. Finally, students assess the criticality of computer systems validation to pharmaceutical manufacturing.
Spring session, City campus
Detailed subject description.