GMP Quality Risk Management – ICH Q9 (R1) Training Course
ICH Q9 (R1) – Overview of this Training Course
This GMP Quality Risk Management Training Course covering ICH Q9 (R1) and Annex 20 GMP requirements is regularly offered in various locations such as Auckland (NZ), Adelaide, Brisbane, Melbourne, Perth and Sydney (Australia), Hong Kong and other areas depending on scheduling availability.
This 1-day Quality Risk Management (QRM) ICH Q9 (R1) training course is focused on:
- how risk management responsibilities and regulations apply to everyday pharmaceutical manufacturing processes
- why it’s important to identify, document and analyse potential hazards and accurately assess the risk to patients
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. It is becoming evident that quality risk management is a valuable component of an effective quality system.
Learn ICH Q9 (R1) and PIC/S Annex 20 GMP requirements
Quality Risk Management & GMP Regulations
What you will learn in this Quality Risk Management Course
Upon completion of this course, participants will be able to:
- understand the basics of hazard identification and risk assessments
- understand the principles of Quality Risk Management (QRM) based on:
- ICH Q9 (R1), and
- PIC/S Annex 20 publications
- 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 and risk-based decisions
- learn the importance of focusing your risk management 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?
- Business Owners/Senior Management Personnel
- Quality Assurance personnel
- Quality Control personnel
- Operations and Manufacturing personnel
- Validation personnel
AUD$500.00 + 10% GST Full Day Virtual Training
AUD$550.00 + 10% GST Full Day Classroom Training
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 at one of our offices around the world.
|Quality Risk Management ICH Q9 Workshop Virtual