Future University In Egypt (FUE)


Future University In Egypt

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Risk Assessment

course code : qc 001

course hours : 24 hours


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.

Learning Outcomes

By the end of the course, the participant will be able to:

  • Identify the process flow chart
  • Identify the process critical parameters
  • Control and monitor the process critical parameters
  • Determine the risk priority number RPN
  • Monitor and improve the process to improve the RPN
  • Develop risk assessment protocol for new process/product
  • Implementing risk assessment protocol for new process/product
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