Pharmaceutical Quality Risk Management-ICH Q9

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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

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.

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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

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.

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.

Gerry Burke

Gerry is a self-motivated medical industry professional with kn...

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John Lafferty

John Lafferty is a Quality professional with over 25 years expe...

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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.

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Snapshot

Course Code

LS041

Duration

1 training day

Delivery Mode

This programme is delivered by or In-Company training

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