Computer System Validation (3 Day)
Unlike many computer validation courses, this pharmaceutical online 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 supported by example test sheets and real-life examples.
Tuesday, 22nd September 2020 to Thursday, 24th September 2020 (3 days)
We use GoToWebinar® 'standard webinars' for our online courses.
Please check your system compatibility before booking
08:00 - 16:00 (London/Dublin)
09:00 - 17:00 (Amsterdam/Berlin)
£1,495 per delegate
NOTE: Course fees will be subject to a 20% UK VAT charge if your billing/invoice address is in the UK and/or delegates are UK based