A detailed overview of Pharmaceutical Quality Management Systems and Regulatory Affairs through evaluating local and international regulations and guidelines; the development and management of total Quality Systems that meet regulatory guidelines; development, management and maintenance of Standard Operating Procedures (SOPs), Deviation/Non-conformance Systems, Corrective and Preventative Action Systems, current Good Manufacturing Practice, (cGMP), Good Laboratory Practice (GLP), Total Quality Management (TQM) ; the function and purpose of International Conference on Harmonization, pharmaceutical regulations in European countries, Japan and USA as well as the regulations in Palestine and other Arab countries; evaluation of Current Pharmaceutical Quality System (ICH Q10). Regulation and licensing of pharmaceutical biotechnology products. (3 Credit hours)
