INTRODUCTION

This course provide the participants with the knowledge and skills to conduct validation for medical device. 

Course Objectives 

• The training provides: 
• Familiarize with the latest FDA guidelines and interpretations of product/process validation. 
• Recognize how Validation Master Plans help the planning process. 
• Differentiate between qualification, verification and validation. 
• Identify if (and when) validations are required. 
• Determine what activities must be completed prior to conducting a validation (confirming) event. 
• Learn how to conduct and document a validation event. 
• Understand what to do when things go wrong (What if's!). 
• Use peer feedback to learn about your own planned or completed validation programs including specific issues and questions.