IQ, OQ, PQ in the Verification and Validation Process 2019

Topics

• The Master Validation Plan(s)
• IQ, OQ, and PQ, major components of robust Verification and Validation programs – Regulatory requirements
• Product Verification and Validation
• Individual V&V Plans and their execution
• QMS V&V and 21 CFR Part 11
• Process and Equipment V&V, including software
• Incorporating the Hazard Analysis / Risk Management tools of ISO 14971 or ICH Q9
• When / How to Use DQ, IQ, OQ, PQ

Who should Attend

• Research and Development Departments
• Quality Assurance Departments
• Manufacturing Departments
• Regulatory Affairs Departments
• Operations Departments
• Engineering Departments
• Validation Departments
• Production Departments
• Documentation Departments
• Software Departments
• CGMP Instructors
• Consultants