Overview: No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. On the other hand it has been is estimated that about 5% of employee's time is spent for training. So there seems to be lack of understanding on what the regulations are, their interpretations and expectations of inspectors.Areas Covered in the Session:GxP training requirements in US and EU Most frequently cited deviationsDeveloping an effective training program for a company, site or department.Developing a training plan for individual employees Who can or should be responsible for the training program and training plans.Most efficient training tools for different tasks.Assessment of successful participationThe benefits of risk based trainingDocumentation of trainings for the FDASpecific training requirements for Part 11Who Will Benefit:Training departmentsQA managers and personnel Analysts and lab managersValidation specialistsRegulatory affairsHuman resources (HR) managers and staffDocumentation departmentConsultants