Course Description

Quality Risk Assessment and Management is regulated by the international organizations such as World Health Organization WHO in the technical report series no. 981 annex2, American Food and Drug Organization FDA in Q9 and regulatory agencies such as Pharmaceutical Inspection Convention PIC/S. This course will cover the following: Regulatory Requirements, principles of quality risk management, planning for risk management, risk assessment, risk control, tools used in risk assessment (FTA, FMEA, etc.). Moreover, quantifying the risk includes: Severity, Probability, Delectability and RPN calculation.