Process Validation

Training Topics:

INTRODUCTION

• • PD Process Development
  • OQ Operation Qualification
  • PD Performance Qualification
• SCOPE
• REFERENCE DOCUMENTS
• RESPONSIBILITIES
• DEFINITIONS, ABREVIATIONS, AND ACRONYMS
• PROCESS VALIDATION PREREQUISITES
• PROCESS THAT SHOULD BE VALIDATED
• ELEMENTS OF PROCESS VALIDATION
• DETERMINING THE SCOPE OF ELEMENTS TO BE COVERED IN THE PROCESS VALIDATION
• CONDUCTING THE VALIDATION

METHODOLOGIES

• FACTORIAL EXPERIMENTS
  • Purpose of Factorial Experimental design
  • Full Factorial Experiments
  • Fractional Factorial Experiments
  • Use of Minitab
  • Examples from real manufacturing processes
• DOE RESPONSE SURFACE
  • Purpose of Response Surface design
  • Response Surface Methodologies and Designs
  • Second – Order Model
  • Use of Minitab
  • Examples from real manufacturing processes
• PROCESS ROBUSTNESS THROUGH VTA
  • Purpose of Robustness
  • Use of MINITAB and VTA (Variation Transmission Analysis) software
  • Examples from real manufacturing processes