Process Validation LifeCycle 2018

Topics

• Process Validation Implementation
  • Drafting the Protocol, Data Gathering, Writing the Report
  • Installation Qualification
  • Drafting the Protocol, Data Gathering, Writing the Report
  • Operational Qualification
  • Drafting the Protocol, Data Gathering, Writing the Report
  • Performance Qualification
• What is Process Validation?
  • Key Definitions
  • Regulatory Requirements
  • The Stages of Process Validation
• Case Studies
  • Warning Letter Review
  • FDA 483 Citation Review

Who should Attend

• Quality Assurance Departments
• Research and Development Departments
• Manufacturing Departments
• Quality Control Departments
• Operations Departments
• Engineering Departments
• Documentation Departments
• Production Departments
• Validation Teams