Validation Academy Program

Validation Academy Program Topics

  • ICH Guidelines (Q8,Q9,Q10), ISPE Guideline and Regulatory Framework for the new approach to qualification
  • Production and Process Controls for Medical Devices (ISO 14971)
  • Risk Based Commissioning and Qualification (Utilities and Equipment)
  • Computer System Validation ­ A GAMP 5 Approach to Data Integrity and Part 11 compliance
  • Environmental Qualification in New Facilities
  • Risk Based Approach to Clean Utilities Qualification (PUR, WFI, Clean Steam, Process Air)
  • Cleaning Validation
  • Regulatory Requirements in a Globalized Industry (FDA, EU, Canada)
  • Laboratory Method Validation