ISO 13485 – IQOQPQ – Process Validation for Medical Devices

Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ) || Medical Devices

Created by: Phaniendra Somraj
ISO 13483 Lead Auditor| Master Black Belt in LSS

What Will I Learn?

• Process Validation of Medical Devices using IQOQPQ Phases to meet ISO 13485 standard requirements and FDA regulations.
• In less than 2 hours you can be an Expert on how to perform Process Validation in your Manufacturing facility
• Create a Process Validation Procedure
• Perform Installation Qualifications
• Perform Operational Qualifications
• Perform Performance Qualifications and launch your New product Introductions regime
• Medical Device Development NPI
• Teach IQ OQ PQ to your teams and collaborate better
• Molding Qualification
• Injection Molding Process Validation

Requirements

• Basic knowledge of Quality inspection will help

Target audience

• Contract Manufacturers, Director of Quality, Quality Managers, Quality Engineers, Supplier Quality Managers, Supplier Quality Engineers, Internal Auditors, Process Engineers, Process Technicians
• Medical Device Industry Quality professionals, Risk Management, FDA 483 responses for Process Validation warning letters
• Mechanical Engineering Students; Sterilization, Passivation, Calibration etc. service providers
• Medical Devices Start Up
• Manufacturing Engineers, Quality Engineers
• Supply Chain Management
• Indian Medical Device Manufacturers and contractors