Practical Steps to Understanding ICH Q9
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Who Should Attend
Drug product team managers, anyone involved in PAT, QbD and other efficiency improvement programs, Pharma
product life cycle planners, regulatory affairs managers, personnel involved with drug development, formulation, scale-up
and drug product management will find this course beneficial.
Description
This 90-minute accredited 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.
Module 1:
Examining the Concept of Risk
• How ICH relates to PAT and QbD
• Risk Identification
• Risk Analysis
• Risk Evaluation
Module 2:
Applying Risk Management
• Risk Assessment Tools
• ICH Q9's Quality Risk Management Process
• To-do Lists
• Using Statistics
Module 3:
Integrating Risk Management with Bio+Pharma Operations
• Basic Risk Management Facilitation Methods
• FMEA-Survey Method
• Fault Tree
Question and Answer Session