Pharmaceutical Quality Risk Management and ICH Q9

The course provides a practical framework for implementing Quality Risk Management in line with ICH Q9. It combines discussion with hands-on activities to ensure learners can apply the methods directly in their workplace. 

Topics include: 

• Understanding the need for Risk Management 
• Key requirements of ICH Q9 
• Relationship to deviations and change control 
• Identifying possible hazards and sources of risk 
• Estimating and reducing risk while minimising subjectivity 
• Risk management techniques: FMECA, HAZOP and Preliminary Hazard Analysis 
• Applying risk management principles to all aspects of quality and service provision 
• Practical risk assessment exercises 

The training involves practical exercises covering all relevant topics, with learners encouraged to work on examples from their own workplace as part of these practical exercises. If required, content may be tailored to reflect your organisation’s specific processes, risk profile and regulatory setting. 

This course is designed for anyone in the pharmaceutical sector who requires a solid foundation in the principles and practice of Quality Risk Management.  It is particularly beneficial for those involved in: 

• Quality and Compliance 
• Production 
• Engineering 
• Research and Development 
• Management and supervisory roles 

A good standard of written and spoken English is important to engage effectively with this programme. 

On successful completion of this course, learners will be able to: 

• Explain the key requirements of ICH Q9. 
• Identify, evaluate and quantify risks using structured methodologies. 
• Apply techniques such as FMECA, HAZOP and Preliminary Hazard Analysis. 
• Assess and determine the acceptability of risks. 
• Apply risk assessment principles to deviations and change controls. 
• Reassess risks following corrective and preventive actions. 
• Correctly apply company-specific risk management procedures and documentation. 

These outcomes ensure that learners return with the practical skills and knowledge necessary to conduct effective risk assessments and embed ICH Q9 principles in their daily work. 

Our tutors are leading industry professionals with extensive expertise in pharmaceutical Quality Risk Management and regulatory compliance. Each Tutor brings a wealth of industry experience, sector-specific insights and a passion for practical training. Their focus is on building learner confidence through engagement, hands-on exercises and personalised support. 

Learners benefit from their practical insight, real examples and ongoing support. 

• 

  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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Our training approach is practical, highly interactive and discussion-based, with flexibility to meet organisational needs 

• Pre-training consultation for in-company courses to tailor content to organisational needs 
• Emphasis on industry specific application through practical exercises, case studies and group activities that reinforce key concepts and encourage active participation. 
• Access to comprehensive course material that is regularly reviewed and updated to reflect the latest industry standards and guidance. 
• Live training is available virtually or delivered onsite to suit the needs of the team 
• Real-time support from expert tutors 

Class sizes are generally limited to 12-15 participants to support personalised learning and individual support. 

Learners who complete this course often continue to deepen their skills in: 

• Mastering CAPA in the Pharmaceutical Industry 
• Process Validation and Equipment Validation 
• GMP for Manufacturers of APIs 
• GMP for Manufacturers of Finished Pharmaceuticals 
• Technical Writing Skills