Pharmaceutical Quality Risk Management and ICH Q9

Home / Risk Management / Pharmaceutical Quality Risk Management and ICH Q9
Quality Risk management is an essential element of any pharmaceutical Quality System designed to assure product quality and achieve compliance with regulations. This course covers risk management principles and good risk management practice as applie... Read More

Quality Risk management is an essential element of any pharmaceutical Quality System designed to assure product quality and achieve compliance with regulations. This course covers risk management principles and good risk management practice as applied to all aspects of pharmaceutical manufacturing testing and distribution. The course is based on the requirements of ICH Q9.

By attending this course, delegates will obtain the tools and skills necessary to carry out risk assessments designed to implement a risk management system in line with ICH Q9. Practical exercises will be completed throughout the day covering real life situations so that delegates can be confident of completing risk assessment when they return to the workplace.

Collapse

What's covered?

Expand/Collapse Expand/Collapse
  • Understanding the need for Risk Management
  • The basic requirements of ICH Q9
  • Relationship to other systems – Deviations and Change Control
  • Identifying possible hazards
  • Estimating the associated risk – removing subjectivity
  • Review and reduction of risk
  • Risk Management Techniques Hazards - FMECA, HAZOP and Preliminary Hazard Analysis
  • How to apply Risk Management to all aspects of Quality and Service Provision
  • Risk assessment practical exercises

Who should participate?

Expand/Collapse Expand/Collapse

Engineers, Scientists, Managers, Production Personal, Quality Professionals and other personnel in the Pharmaceutical industry who need to gain a solid foundation in the principles and practices of Quality Risk Management.

What will I learn?

Expand/Collapse Expand/Collapse

Participants will achieve the following learning outcomes from the programme;

  • State the basic requirements of ICH Q9.
  • Identify and quantify risks.
  • Decide on the acceptability of those risks.
  • Re-evaluate risks following corrective action.
  • Use techniques such as FMECA, HAZOP and Preliminary Hazard Analysis.
  • Apply risk assessment to Deviations and Change Controls.
  • Comply with company risk management procedures and complete associated documentation correctly.

Who are the tutors?

Expand/Collapse Expand/Collapse

How do we train and support you?

Expand/Collapse Expand/Collapse

In-House Courses
Course tutor will contact your organisation in advance to discuss the programme in detail.
In-house courses can be customised to meet your organisation’s specific requirements.

Course Manual
Delegates will receive a comprehensive course manual with relevant course materials.

Share this Programme

SnapshotSnapshot

Course Code
LS041
Duration
1 training day
Delivery Mode
This programme is delivered by or In-Company training
stdClass Object
(
    [primary_category] => Risk Management
    [primary_slug] => risk-management
    [categories_slugs] => Array
        (
            [0] => new-2024
            [1] => risk-management
        )

    [parent_categories_slugs] => Array
        (
            [0] => life-sciences
            [1] => life-sciences
        )

)

What Our Learner's SayWhat Our Learner's Say



Super good training, very interesting.
Elena L July 3, 2024
Great course delivered by a great tutor.
Andrew M July 3, 2024
John was fantastic. He made sure everyone was on the same page. Very friendly and easily approachable if questions popped up.
Laela M July 3, 2024
John was very good kept the class alert and interactive which helped with the delivery
Sarah K July 2, 2024

Pharmaceutical Quality Risk Management and ICH Q9

Hide

Pharmaceutical Quality Risk Management and ICH Q9

Duration: 1 day
Hide