Risk Hazard Assessment for Validation - ISO 14971 Training Course :

<strong>Course Schedule - Pre-recorded Course</strong><br/><br/>This program is designed to introduce the concept of Risk/Hazard Assessment. It addresses when to do an assessment, what tools are available, what the FDA expects and how it can save you time, money and resources. By understanding Risk Assessment participants will be able to use the techniques and tools to: prioritize and plan validation projects and submissions, plan testing, and define “what is enough “and when they are “done.”<br><br> <b>Module 1: Define computer system validation:</b> <li>FDA’s definition</li> <li>Tasks<br></li><br><br> <b>Module 2: FDA Guidelines:</b> <li>Least burdensome approach</li> <li>The role of Risk Assessment</li> <li>When is Risk Assessment required<br></li><br><br> <b>Module 3: Tools and Techniques:</b> <li> ISO 14971</li> <li>FMEA</li> <li>Fault Tree</li> <li>HACCP</li> <li>Root Cause-5 Why’s</li><br><br>