Course Introduction
The course provides an introduction to quality risk management and is made up of eight learning Modules. The course covers the key definitions and terminology involved in quality risk management and how it relates to other standards and guidance, the principles and process of quality risk management, corporate governance, risk and implementing quality risk management.
Course Key Points
The course includes:
- An understanding of the key definitions - What is risk, risk management and quality risk management and the relationship between ICH Q9 and Q8 and Q10
- An understanding of the process and principles of ICH Q9 and the importance of corporate governance
- A walk through of risk assessment, risk management methods and tools, risk control, risk review and risk communication
- An understanding of the key considerations during the implementation of quality risk management
Course Author
Trev Simmons, A1 IT Compliance has worked in the pharmaceutical industry since 1994. He has held a variety of roles specialising in pharmaceutical IT & validation, from developer to project/validation manager through to quality management and quality assurance. His experience includes IT/CSV quality assurance and quality risk management across all the GxPs. Trev is a course principal/tutor for both the RQA Professional Development and eLearning quality risk management courses.