Computer System Validation
This course provides attendees with up-to-date and detailed information that should help them tackle the many diverse challenges of validating and operating computerised systems in a compliant and risk based way. The course aims to cover all the key areas that need to be considered when qualifying and operating computerised systems. These include: the types of computer/computerised systems and their elements; key regulations and guidance (including GAMP 5 2nd Edition ); data management and data integrity; the general principles of risk based validation; validation planning/approaches/activities; supplier governance; data migration; current trends; operational phase activities; infrastructure management; and periodic system review. It will also include an example infrastructure project and the qualification of: Packaged Systems (Equipment Control Systems); Distributed Control Systems; Laboratory Systems; Information/Business Systems and Spreadsheets. The presentations will include real life examples and the learning experience will be enhanced by using carefully structured workshops. Attendees will receive PDF file versions of all the presentations by email. Presentations for each day will be sent out the day before the start of the respective day of the course.