Practical Steps to Understanding ICH Q9 Training Course :

<strong>Course Schedule - November 18, 2008 at 11:00 a.m. - 12:30 p.m. (EST) </strong><br/><br/>This 90-minute <b><i>accredited</b></i> online training will cover the progression of pharmaceutical development as defined in ICH Q8 and its transition into quality management systems. In addition, the course will explore a series of production evaluation, analysis and optimization approaches that will help participants to rank and evaluate quality systems.<br><br> <b><u>Module 1:</u><br> Examining the Concept of Risk</b><br>   • How ICH relates to PAT and QbD<br>   • Risk Identification<br>   • Risk Analysis<br>   • Risk Evaluation<br><br> <b><u>Module 2:</u><br> Applying Risk Management</b><br>   • Risk Assessment Tools<br>   • ICH Q9's Quality Risk Management Process<br>   • To-do Lists<br>   • Using Statistics<br><br> <b><u>Module 3:</u><br> Integrating Risk Management with Bio+Pharma Operations</b><br>   • Basic Risk Management Facilitation Methods<br>   • FMEA-Survey Method<br>   • Fault Tree<br><br> <b>Question and Answer Session</b>