Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for their intended use. To be acceptable to regulatory authorities, electronic records must comply with 21 CFR Part 11, Annex 11 to EU GMPs and more recent data integrity guidance’s. Recent EU and FDA regulatory enforcement actions demonstrate that qualification, validation and electronic records are priority areas for inspection. Recently there have been many FDA warning letters and the frequency of EU enforcement action in these areas.
This training course guides you through equipment qualification, calibration and computer system validation processes from planning to reporting. It also explains regulatory requirements in these areas, including EU and US GMPs, as well as data integrity guidances from national and international regulatory sources. Once completed you will have the confidence to conduct analytical instrument qualification and computer system validation, ensuring you are compliant with global regulations.
With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.