Diploma

Quality Risk Management (QRM)

Quality Risk Management is an essential part of quality management within the pharmaceutical industry and the are several methods and models to choose from. 

Skills obtained
 
The participant of the course has gained knowledge within: 
 

• Overview of ICH Q9 and the new ICH Q9 (R1) 
• Principles in Quality Risk Management (QRM) 
• Key terms such as
  • Harm
  • Hazard
  • Risk
• The structure in a risk assessment and understanding of the terms
  • Severity
  • Probability
  • Detectability 

• Ideas for risk mitigation in either design, procedure, or test 
• The most common methods and tools for risk management including:
  • Process mapping
  • Brainstorming
  • Fishbone/Ishikawa
  • X times why
  • FMEA & FMECA
  • HAZOP
  • PHA
  • HACCP
  • Fault Tree Analysis
  • Risk Ranking & Filtering

• The strength and weaknesses of the individual methods and tools
• The interdependence and interaction between the methods and tool
• Risk analysis in Computerized Systems (from GAMP5)