Pharmaceutical Quality Risk Management Training Course – ICH Q9

Pharmaceutical Quality Risk Management Training Course Overview

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.”

Course Duration & Location

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.

Pricing

Our 2018 pricing is A$350 per person or A$3500 per day plus GST for up to 15 participants. This does not include travel costs.

*Smart device and WiFi is needed for all attendees.

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

What you will learn

Upon completion of this course participants will be able to;

  • understand the basics of 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

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.

EventVenueDate
Melbourne Quality Risk Management Training (ICH Q9)PharmOut Training Centre
  • 18/06/2019 9:00 am
Register
Sydney Quality Risk Management Training (ICH Q9)Eden Gardens and Garden Centre - Sydney
  • 20/06/2019 9:00 am
Register