Quality Risk Management Training - Pharmaceuticals

Course code:PQRM01

Overview

This course is covers the key concepts of ICH Q9 and ATSM 2500E and how to apply them to pharmaceutical manufacturing.

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. If your site is not in a city we have an office in then we ask you to cover the travel costs from our nearest office. You'll save the costs associated with your staff travelling to be trained, so it becomes cost effective if you have several people needing training.

Pricing

Indicative pricing is A$450 per person, with discounts available when more than 10 people attend the same course.

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.