Global Learning for Operational Leaders
Classroom
14 sessions
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Online / Live
14 sessions
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Introduction
Course overview
Pharmaceutical, biotechnology and medical device organisations must manage quality risks to protect patients and comply with regulators. Risk-based approaches help focus resources on what matters most for product quality.
This Aractech course explains quality risk management principles and processes aligned with ICH Q9, risk assessment tools such as FMEA, HACCP and risk ranking, risk control and review, integration with the pharmaceutical quality system, and documentation expected by inspectors. Participants conduct risk assessments on realistic cases.
The course suits quality, manufacturing and regulatory professionals in life sciences.
What you will achieve
Learning objectives
- Explain quality risk management principles and ICH Q9
- Apply risk assessment tools appropriately
- Evaluate and control quality risks
- Integrate QRM into quality systems
- Document risk assessments for inspections
- Review and communicate risks
Who should attend
Target audience
- Quality assurance professionals in pharma and biotech
- Manufacturing and validation staff
- Regulatory affairs professionals
- Quality control laboratory managers
- Medical device quality staff
- Auditors
Methodology
Learning approach
- Regulatory-focused presentations
- Risk assessment workshops
- Case studies
- Documentation reviews
- Group discussions
Complete course outline
Five focused days of learning and application
The timings provided are estimates and may vary depending on the number of participants and the discussions taking place during the sessions. They are indicative only and do not constitute a binding commitment.
Day 1
QRM Principles
- Patient safety focus
- ICH Q9 overview
- QRM process
- Subjectivity in risk
- Coffee break
- Subjectivity in risk (continued)
- Regulatory expectations
- Exercise: Risk question formulation
Day 2
Risk Assessment Tools
- Risk ranking and filtering
- FMEA
- HACCP
- Fault tree analysis
- Coffee break
- Fault tree analysis (continued)
- Tool selection
- Workshop: FMEA for a process
Day 3
Risk Control and Review
- Risk reduction
- Risk acceptance
- Review and monitoring
- Change control links
- Coffee break
- Change control links (continued)
- Deviation management
- Exercise: Risk control plan
Day 4
Integration with Quality Systems
- Quality systems
- Validation
- Supplier management
- Data integrity
- Coffee break
- Data integrity (continued)
- Case study: Inspection finding
- Exercise: QRM integration
Day 5
Documentation and Communication
- Documenting assessments
- Inspection readiness
- Risk communication
- Coffee break
- Risk communication (continued)
- Governance
- Improvement
- Capstone: QRM report
FAQ
Frequently asked questions
What does Quality Risk Management for Life Sciences (QP-020) cover?
This course covers Quality and Productivity through a structured five-day outline focused on practical application, discussion, and implementation planning.
When is the next available session?
The next scheduled session starts on 16 - 20 November 2026. See the course schedules section for the available dates and delivery formats.
Who should attend this course?
Quality assurance professionals in pharma and biotech, Manufacturing and validation staff, Regulatory affairs professionals
Is bilingual course delivery available?
Yes. All course materials and presentations are provided in English, while bilingual explanation and discussion support may be available depending on the selected location and trainer availability. For example, when attending a course in Istanbul, you may request a Turkish-speaking trainer to explain the English course content in Turkish. Arabic explanation support may also be requested at this location. Other languages are available in selected cities. You can choose your preferred language support as an optional preference during registration.
How can I register for a session?
Use any Register button next to the available course dates to open the participant registration page and submit your booking request for the selected session.
Is this course available online as well as classroom-based?
Check the course schedules section for currently published classroom and Online / Live sessions.
Where are classroom sessions delivered?
Current classroom venues include Paris, Frankfurt, Amsterdam, Geneva, Istanbul, Cape Town, Barcelona, Vienna.
How long is the training programme?
The programme runs for five days from 09:00 to 14:00, which gives 25 contact hours, including a daily 30-minute break (22.5 hours of instruction).
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