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This training session help viewers to learn -
Brief introduction of the topic and scope
Brief on ICH Quality Guidelines
Understanding guideline for Quality Risk Management
Updates in new version of guideline ICH Q9 (R1)
Understanding of - Managing your risk has its own rewards.
Role of ICH Q9 with ICH Q8 and ICH Q10
Practical understanding on QRM process and how to perform QRM by FMEA tool.
Action Priority Tablet concept/Heat map matrix
Vote of Thanks - Q&A session
If you need an example for how to use FMEA tool - Go through the link of video (10 minutes duration). At the last - I have given the practical example.
Link: • Quality Risk Management
26 авг 2024