Risk Management in Pharmaceutical Operations (ICH Q9)

Aims:     
To provide an introduction to the principles of risk management and its application in the pharmaceutical and related industries. To enable students to identify opportunities and apply risk principles within their GxP related operational areas.

Outline Syllabus:

• Principles of risk management (analysis, control and management)
• Regulatory guidance for applying risk management in pharmaceuticals  – FDA, EU/PICs/TGA, ICH
• Risk analysis and risk control applications in design control – using the medical devices cascade model
• Quality by Design - Risk analysis in design and development of products
• Application of risk analysis and risk to quality management systems and CAPA systems
• Application of risk assessment for managing product complaints
• Application of risk analysis in compliance and auditing of pharmaceutical operations
• Hazard Analysis and  Critical Control Point (HACCP) in production and process control
• Application of risk principles in commissioning, qualification and process validation
• Development a of Risk Management Master Plan

Learning Outcomes:
On successful completion of this module, the student will be able to:

(1) Knowledge and Understanding

• Explain the elements of a risk management program for pharmaceuticals
• Identify and interpret the regulatory requirements for application of risk principles
• Explain the principles and requirements of ICH Q9 – Quality Risk Management Guideline
• Describe the contents of a risk management master plan for pharmaceutical operations
• Identify risk principles and practices relevant to the following areas:
  • Quality Management Systems
  • Corrective and Preventive Action (CAPA) programs
  • Compliance and audits
  • Management of Product Complaints
  • Process controls
• State how risk management principles may be used to optimize commissioning, qualification and validation of pharmaceutical operations
• Interpret how risk assessment principles and risk control are applied to new product design and development
• Explain risk analysis principles and how they are applied to manufacturing processes

(2) Discipline skills

• Develop a risk management master plan for a pharmaceutical operation
• Develop risk management applications for site quality assurance programs
• Use risk analysis tools to analyse a manufacturing processes
• Apply risk management practices to CAPA, auditing and compliance programs
• Apply risk assessment strategies to commissioning, qualification and validation programs
• Utilise the principles of risk assessment and risk control management in product design and development