Unlike many computer validation courses, this pharmaceutical training course concentrates on what actually works in real life with respect to the quality management, operation and qualification of computerised data management (business) systems and equipment control systems. This will be supported by the high level of relevant and recent practical knowledge of the presenters involved.
The first part of the course covers the general theory and terminology relating to the validation phases and will encompass current applicable regulatory rules/guidance and international standards/guidelines (including GAMP 5). It will also cover the operational and quality management activities relating to: routine operation/management; system/process/validation review; data management and system retirement. The course has been been fully updated with the very latest guidance on DATA INTEGRITY by the FDA, MHRA and WHO.
The second and major part of the course will be dedicated to working through, in a very practical way, qualification activities/testing relating to key areas of computerised systems such as: infrastructure qualification/verification; packaged system qualification/verification; IS Systems (data management systems); and plant /equipment control systems. This will be heavily supported by example test sheets and real-life examples.