3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process

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

Attendees from:

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