GMP Quality Risk Management (ICH Q9) Training Course
This GMP Quality Risk Management Training Course is regularly offered in Auckland, Adelaide, Brisbane, Hong Kong, Melbourne, Perth and Sydney. It 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 Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH):
The importance of quality systems has been recognised in the pharmaceutical industry and it is becoming evident that quality risk management is a valuable component of an effective quality system.
What you will learn
Upon completion of this course participants will be able to:
- understand the basics of Quality Risk Management based on ICH Q9 and PIC/S PE 009 Annex 20
- discuss techniques such as PHA, FMEA 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.
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.
The GMP Quality Risk Management Training 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
AUD $450.00 + 10% GST
Prices are per person and include morning tea, lunch and afternoon tea (excluded for Virtual Training).
Register for a GMP 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.