Graduated from China Pharmaceutical University, starting her professional work in 2001, Katie now has accumulated more than 10-year-experience with GMP. She has accumulated her quality management experiences, especially GMP experiences, from total quality management work. She has once been a QA manager and a delegated qualified person. She has experience at first hand in preparation for EU GMP, such as establishing and improving the six necessary quality systems, that is Validation System, Laboratory Control System, Production and process control systems, Quality Assurance System, Material Control System and Documentation System, etc. She knows well how to control the entire quality system fully to meet the GMP requirements.