Pharmaceutical Quality Risk Management Training Course – ICH Q9

Pharmaceutical Quality Risk Management Training | Course Overview | ICH Q9

This Quality Risk Management training is focused on how the regulations apply to everyday pharmaceutical manufacturing processes and to accurately assess the risk to the patient.

As discussed at the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use:

“…the importance of quality systems has been recognized in the pharmaceutical industry and it is becoming evident that quality risk management is a valuable component of an effective quality system.”

Duration and Locations for  Quality Risk Management | Pharmaceutical Training Course

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

PharmOut’s training courses can be delivered anywhere in the world, we will ask you to cover reasonable travel costs, with this you could save the costs associated with your staff travelling to a external venue to be trained, so it becomes cost effective if you have several people needing training.

PRICE: Quality Risk Management Training Costs | Certificate Course Options

Pricing per course is A$400 per person or A$4,000 per day plus GST for up to 15 participants.

This does not include travel costs.

*Smart device and WiFi may be needed for attendees for certain courses.  If so, this will be designated in your registration confirmation materials.

Contact us for a quote if you need more that 10 trainees to be trained.

What you will learn in this Pharmaceutical Risk Management course (ICH Q9)

Upon completion of this course participants will be able to;

  • understand the basics of Pharmaceutical Quality Risk Management
  • discuss techniques such as PHA, FEMA and HACCP
  • understand the basics of applying effective Quality Risk Management mechanisms
  • contribute and add value to the Quality Risk Management process
  • understand risk based compliance, risk based decisions and be able to focus efforts on the greatest risks to patient safety and product quality
  • do basic risk modelling
  • prioritise workloads according to risk management
  • devise risk reduction and mitigation strategies that actually achieve their purpose
  • understand how knowledge of your product and processes can lead to profitability

Course materials and Slides for Pharmaceutical Risk Management Training | ICH Q9 Resources

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.


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 about Quality Assurance ICH Q9, Risk Management and GMP Courses by leading consultants to the Pharmaceutical Industry

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