ISO14971 Quality Risk Management Training for Medical Devices

ISO14971 Quality Risk Management Training for Medical Devices

Overview

This introductory one day course is regularly offered in Auckland, Adelaide, Brisbane, Hong Kong, Melbourne, Perth and Sydney and covers the key concepts of ISO 14971:2007 and how to apply the standard to the medical devices industry.

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.

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.

What you will learn

Upon completion of this ISO14971 Quality Risk Management Training for Medical Devices 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 ISO 14971 and ICH Q9 and the relationship between these key documents
  • understand how Risk Management can improve your company’s bottom line
  • discuss Risk Management compliance requirements

 

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 ISO14971 Quality Risk Management Training for Medical Devices is a combination of lecture-style learning and active workshops, with participants working in small groups on assigned tasks and case studies.

Who should attend?

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

 

AUD$400.00 + 10% GST

Prices are per person and includes morning tea, lunch and afternoon tea

Register for an ISO14971 Quality Risk Management Training Course below:

If you need any assistance, would like a quote for personalised group training, or just have a general training question don’t hesitate to contact us.

EventVenueDate
Melbourne ISO 14971 Quality Risk Management TrainingPharmOut Training Centre
  • 06/06/2019 9:00 am
Register
Sydney ISO 14971 Quality Risk Management TrainingEden Gardens and Garden Centre - Sydney
  • 28/06/2019 9:00 am
Register

Course Code: PO1818