Process Validation - Overview of Why and How 2019

Topics

• Why is process validation necessary
• What is process validation
• How to determine if a process requires validation
• Process validation guidelines
• Process validation outline
• What processes should be validated
• OQ – Operational Qualification
• IQ – Installation Qualification
• Process monitoring
• PQ – Performance Qualification

Who should Attend

Attendees from:

• Manufacturing engineers
• Quality Engineering
• Compliance
• Internal auditing
• Quality Managers new to medical devices or process validation
• Others in Quality
• Medical device consultants new to process validation
• Operations/Manufacturing Managers new to medical devices or process validation