Quality Risk Management Training

Course code: DQRM03

Overview

This introductory one day course is covers the key concepts of ISO 14971:2007 and how to apply the standard.

As stated in the standard:

"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."

Course Duration & Location

One day, on your site or at an offsite location.

PharmOut's training courses can be delivered anywhere in the world. If your site is not in a city we have an office in then we ask you to cover the travel costs from our nearest office. You'll save the costs associated with your staff travelling to be trained, so it becomes cost effective if you have several people needing training.

Pricing

Indicative pricing is A$450 per person, with discounts available when more than 10 people attend the same course.

What you will learn

The following topics are covered in the course:

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.

Upon completion of this course participants will be able to;

• understand the critical processes of Quality Risk Management in a Medical Device context
• know key features of various Risk models including, FMEA, FMECA, HAZOP and HACCP
• understand Risk Based compliance, Risk Based decisions and how to focus efforts on the greatest risks to patient safety and product quality
• understand what regulators will expect in Quality Risk Management policies, procedures and justification documents
• completely understand the ISO14971-2007 Standard
• understand ISO14971 and ICHQ9 and the relationship between these key documents
• understand how Risk Management can improve your company's bottom line
• discuss Risk Management compliance requirements

The course also includes a facilitated session where the class will discuss current issues facing participants, with the aim of determining a course of action to be implemented back in the workplace.

Course materials

Participants will receive a copy of the presentation(s), relevant notes and workshop materials.

A certificate of completion will be issued to participants who successfully complete the assessment.

Assessment

A written assessment is conducted at the end of the course.

Course Format

The course is a combination of lecture-style learning and active workshops with participants working in small groups on assigned tasks.

Who should attend?

• Quality Assurance personnel
• Quality Control personnel
• Operations and Manufacturing personnel
• Validation personnel

More information

If you would like a quote or would need to ask questions, please contact us.