Quality Risk Management for Life Sciences (QP-020) Training Course

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 or online

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

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.

Can I take Quality Risk Management for Life Sciences online?

Yes. Every date can also be joined live online in a virtual classroom with the trainer, for £1,280 per participant. Choose "Live online" in the dates table when you register.

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.

Quality Risk Management for Life Sciences

Course overview

Course outline

Dates and fees

Frequently asked questions

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