Pharmaceutical Quality Risk Management

This course is covers the key concepts of ICH Q9 and how to apply these to pharmaceutical manufacturing.

As stated by 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

3-5 days, on your site or at one of our training centers.

CiPharma’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.

What you will learn

  • 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
  • Prioritize 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 or Manufacturing personnel
  • Validation personnel