Has the Computer System Validation Engineer left and you’ve been handed their responsibilities? Do the thoughts of your next audit fill you with dread? CSV can be frustrating but this program will show you how to manage electronic data in a regulated manufacturing/laboratory/clinical environment using the GAMP framework and ensure compliance with FDA’s 21 CFR Part 11, EU Annex 11 or other regulatory guidelines.
Evaluate your training programmes overall effectiveness in addition to assessing training at learner or course level. Discover how to demonstrate value through return on investment (ROI) or non-financial return on expectation (ROE) to create compelling business cases and management reports. With practical advice on how to monitor and measure your results against department key performance indicators (KPI’s).