Quality Risk Management for Medical Devices 03 (DQRM03)
This introductory one day course is outlines the key concepts contained in ISO 14971:2007 and how to apply the standard.
For example;
- Quality Assurance personnel
- Quality Control personnel
- Operations and Manufacturing personnel
- Validation personnel
“This International Standard specifies a process through which the manufacturer of a medical device can identify hazards associated with a medical device, estimate and evaluate the risks associated with these hazards, control these risks, and monitor the effectiveness of that control.” – ISO 14971:2007 Medical devices - Application of risk management to medical devices
Learning Objectives and Course Description
This course participants will discuss advanced concepts contained in ISO 14971:2007 and will cover specific techniques such as -
Preliminary Hazard Analysis (PHA)
PHA is an inductive method of risk analysis with the aim of identifying any hazards, hazardous situations and events that can cause harm for a given process, facility or system. Most commonly practised in the early stages of project development when design detail may be lacking. Considers materials, equipment and operating environment variables among others.
Fault Tree Analysis (FTA)
A ‘top down’ approach to hazard analysis. Starting at a top event, FTA uses a deductive process and a stepwise identification of undesirable system operation to reduce risk. A simple method that uses diagrammatic representation of processes for people to quickly and effectively estimate and control risk.
Failure Modes Effect Analysis (FMEA)
The “what happens if...” approach. A method that analyses one line item at a time and is a bottom up approach that seeks to control risk at the next functional level to original risk identification.
Hazard and Operability Study (HAZOP)
HAZOP is based on a theory that assumes accidents are caused by deviations from the design or operating intentions. Team based approach that is similar to FMEA in its interpretation and analysis of risk.
Hazard Analysis Critical Control Point (HACCP)
Originally developed by NASA to prevent food poisoning of astronauts, HACCP is a commonly used risk management model that focuses on the control and monitoring of initiating risk factors that cause product hazards originating in manufacturing processes in particular.
This one day course is intended to provide participants with a working knowledge (illustrated by recent examples) and understanding of the current cGMP.
- understand the critical processes of Quality Risk Management in a Medical Device context
- key features of various Risk models including, FMEA, FMECA, HAZOP and HACCP
- Risk Based compliance, Risk Based decisions and how to focus efforts on the greatest risks to patient safety and product quality
- know what regulators will expect in Quality Risk Management policies, procedures and justification documents
- completely understand the ISO14971-2007 Standard
- ISO14971 and ICHQ9 and the relationship between these key documents
- understanding how Risk Management can improve your company’s bottom line
- Risk Management compliance requirements
Benefits include
- learning from experienced professional trainers
- understanding Risk Management and its applications for managerial and technical professionals
- classes are small and intimate
- receipt of a complete training kit, trainer’s notes and a certificate of completion for participants assessed.
View schedule and how to make a booking.
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