Process validation & qualification, including validation methods

This course provides candidates with practical tools for validation including, qualification, process validation and analytical method validation. Incorporating facility/equipment qualification, process validation and validation of analytical methods for requirements in Europe, US and elsewhere, including ICH.

This course is suitable for those working in most pharmaceutical companies e.g. those producing novel medicines, generics manufacturers, ‘virtual’ companies, suppliers/contract manufacturers, etc. It is applicable to scientists, engineers, validation professionals working in development, manufacturing, quality, support functions, engineering, validation and other related departments.

This course is suitable for those working in most pharmaceutical companies e.g' those producing novel medicines, generics manufacturers, ‘virtual’ companies, suppliers/contract manufacturers, etc. It is applicable to scientists, engineers, validation professionals working in development, manufacturing, quality, support functions, engineering, validation and other related departments.

• Why validate?
• International regulatory requirements, e.g. US, EU & elsewhere
• Science and risk -based approaches
• The 3 stages of the validation life-cycle (Ref FDA & EU)
• Tools to enable effective validation such as:
  • Understanding product and manufacturing process requirements
  • Importance of Control Strategy
  • Application of Quality Risk Management
• Readiness
• Process validation
• Determining the number of validation batches
• Qualification of equipment and utilities
• Maintaining control of product life-cycle, including monitoring 
• Analytical validation:
  • ICH Q2 principles
  • Analytical method validation