Quality Risk Management in Pharmaceuticals
The training lecture will help you to learn a brief introduction of the topic and scope Brief on ICH Quality Guidelines and Understanding guidelines for Quality Risk Management Updates in the new version of the 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 of Quality Risk Management (QRM) process and how to perform QRM by failure mode effect analysis tool. Action Priority Tablet concept/Heat map matrix Vote of Thanks – Q&A session.
What you’ll learn
- Performing quality risk management.
- Practical implementation of QRM.
- Updates in quality risk management.
- This course is self made for personal upgradation in pharmaceuticals.
Course Content
- Introduction –> 5 lectures • 2hr 31min.
Requirements
The training lecture will help you to learn a brief introduction of the topic and scope Brief on ICH Quality Guidelines and Understanding guidelines for Quality Risk Management Updates in the new version of the 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 of Quality Risk Management (QRM) process and how to perform QRM by failure mode effect analysis tool. Action Priority Tablet concept/Heat map matrix Vote of Thanks – Q&A session.
Further, there is a small video lecture that will help you to understand Quality Risk Management principles, how it is simple and easy to implement and achieve the compliance level. We have explained this with simple examples.
The last lecture video will help you to learn further about Good Review practices. This training will include, some examples of Food and Drugs Administration (FDA) citations, regulatory expectations about the review, 10 key principles about good review practices, how to qualify reviewers, and many more.
Overall this training session will take you through an understanding of quality risk management, what is updated in the revised ICH Q9(R1) guideline, with practical examples and good review practices based on risk-based approach.