Quality Risk Management QRM (eLearning)
This highly interactive three-hour eLearning course is based on RSSL’s popular 1-day Quality Risk Management tutor-led course. Through self-directed study, learners will gain insights aligned to the latest science and risk-based principles and regulatory guidance in the EU and US. The course delves into detail on the steps involved in carrying out a risk exercise, from the initiation stage to completion and review. It also covers the intent and outlined content of the ICH Q8(R1).
Before purchasing this module, you can book the free trial version to check that the content and level of the course is right for you.
This course is suitable for people in development, manufacturing, engineering or validation who may have no, or limited quality risk management experience or for those with experience but who wish to be updated with the latest application, particularly regarding science and risk-based principles.
This course takes approximately 3 hours to complete and comprises the following key modules:
Regulatory background - EU, US, ICH
ICH Q8/11 – product and process understanding
ICH Q9 – principles and tools
Setting up and running an FMEA
Pulling it all together
Review of latest draft of ICH Q9(R1)
By the end of the course, delegates will:
Understand the regulatory drivers for QRM, with particular emphasis on European and US requirements and expectations
Understand how ICH Q9 underpins ICH Q8, Q10 and Q11 for activities in development, manufacturing, engineering and process validation
Understand the principles of QRM, the ICH Q9 framework and the importance of common language and approaches, and the differences between QRM and risk analysis
Understand how to set up and run a risk management exercise, including team selection, risk assessment, analysis, control, review and communication
Recognise the importance of product Critical Quality Attributes, Critical Process Parameters and Control Strategy in regard to science and risk-based principles
Appreciate how to use FMEA, risk ranking, cause effect matrix and other related Risk Analysis techniques, such as process flow diagrams, ‘fishbone’, ‘brainstorming’ etc.
Have knowledge of the background and detail of the ICH Q9(R1)
As scientists ourselves, we’re passionate about collaboration and sharing our expertise to nurture the next generation. By helping them to develop and fulfil their potential, we can tackle 21st-century pharmaceutical scientific challenges more effectively.
More than 30 years of experience upskilling pharmaceutical professionals
Small-group training adjusted to individual learning styles and needs
50+ training courses accredited by recognised industry bodies
Combination of off-the-shelf and bespoke training packages
Courses and consulting led by experts in the entire pharmaceutical life cycle
Opportunity to share and learn as part of a diverse community
