Successful completion of this one day course provides the delegate with understanding of the principles of Quality Risk Management (QRM) and its practical application.
The course is focused on ICH Q9 (QRM) and its support to ICH Q8 (Pharmaceutical Development), Q10 (Quality Systems) and Q11 (Drug Substance Development) along with its practical application in development, manufacturing, engineering and validation.
The course will be aligned to the latest science and risk based principles and regulatory guidances in the EU and US.
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.
By the end of the course you will be able to:
- 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.
- Appreciate the importance of QRM documentation and Risk Registers
- Welcome and Introduction & Participant Objectives
- Regulatory Background - EU& US & ICH
- ICH Q8/11 – Product & Process Understanding
- ICH Q9 – Principles & Tools
- Setting up and Running an FMEA
- Pulling it all Together
- Exercise - Your Action Plan