Description
<strong>Course Schedule - November 18, 2008</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>
11/13/2008
To
01/01/0001
Training Company
The Center for Professional Advancement (CfPA)
Industry
Pharmaceutical
Course Category
Brochure Name
http://www.cfpa.com/PDF/2008/2160,C8-283,0811-308.pdf
Address
90 Minute Accredited Online Training Online Training