Advanced Quality Excellence and Facilities Management
Next: 16 - 20 Nov 2026 · Barcelona
Barcelona, Amsterdam, Paris +3 more
Professional training course · QP-020
Quality Risk Management for Life Sciences
Pharmaceutical, biotechnology and medical device organisations must manage quality risks to protect patients and comply with regulators. Risk-based approaches help focus…
- 5 daysClassroom
- 14Upcoming dates
- 8Cities
- £2,840Fees from
Course overview
Why Attend
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 LLMI 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.
Course 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
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
Course Methodology
Regulatory-focused presentations
Risk assessment workshops
Case studies
Documentation reviews
Group discussions
Course outline
-
1Day 1: QRM Principles
- Patient safety focus
- ICH Q9 overview
- QRM process
- Subjectivity in risk
- Regulatory expectations
- Exercise: Risk question formulation
-
2Day 2: Risk Assessment Tools
- Risk ranking and filtering
- FMEA
- HACCP
- Fault tree analysis
- Tool selection
- Workshop: FMEA for a process
-
3Day 3: Risk Control and Review
- Risk reduction
- Risk acceptance
- Review and monitoring
- Change control links
- Deviation management
- Exercise: Risk control plan
-
4Day 4: Integration with Quality Systems
- Quality systems
- Validation
- Supplier management
- Data integrity
- Case study: Inspection finding
- Exercise: QRM integration
-
5Day 5: Documentation and Communication
- Documenting assessments
- Inspection readiness
- Risk communication
- Governance
- Improvement
- Capstone: QRM report
Dates and fees
Questions
Frequently asked questions
How long is the Quality Risk Management for Life Sciences course?
The course runs over 5 days of classroom training, usually Monday to Friday.
When is the next Quality Risk Management for Life Sciences course?
The next public date is 16 - 20 Nov 2026 in Paris. There are 14 upcoming dates in total.
Where is this course held?
Upcoming sessions run in Paris, Frankfurt, Amsterdam, Geneva, Istanbul, Cape Town, Barcelona, Vienna.
How much does the course cost?
Fees start from £2,840 per delegate, depending on the city. Fees include tuition and course materials.
Do participants receive a certificate?
Yes. Delegates who complete the course receive a London Leadership Management Innovation certificate of completion.
Can this course be delivered in-house for our team?
Yes. LLMI can tailor and deliver this course privately for your organisation at your premises or in one of our training cities.
Course information last updated 14 November 2026.
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