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Clara Fargo
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Quality Risk Management Course & Certification
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About
The Quality Risk Management (QRM) Course & Certification is designed to provide a structured understanding of risk-based approaches used to ensure quality, safety, and compliance in pharmaceutical, biotechnology, and life sciences industries. The course focuses on identifying, assessing, controlling, and monitoring risks across regulated processes in alignment with global regulatory expectations.
This course covers QRM principles, ICH Q9 guidelines, risk assessment tools (FMEA, HACCP, risk ranking), risk control strategies, documentation practices, and lifecycle management of risks. It also emphasizes integration of QRM into quality systems, deviation management, change control, and inspection readiness. Upon successful completion, learners receive a certification demonstrating competency in Quality Risk Management practices.
Who Should Enrol?
- Quality Assurance and Quality Control Professionals
- Validation and Compliance Teams
- Regulatory Affairs Professionals
- Manufacturing and Production Staff
- Clinical Research and Pharmacovigilance Professionals
- Pharmaceutical, Biotechnology, and CRO Employees
- Life Science, Pharmacy, Chemistry, and Engineering Graduates
What you will learn
Understand the fundamentals of Quality Risk Management (QRM), including its purpose, scope, and regulatory expectations in pharmaceutical and life sciences industries.
Learn the core principles and structured process of QRM, including risk identification, assessment, control, communication, and review.
Gain knowledge of key QRM methodologies and tools used to support decision-making and ensure product quality and patient safety.
Develop an understanding of how QRM is applied in pharmaceutical manufacturing and regulatory affairs to ensure compliance and continuous quality improvement.
Course Syllabus
- Why Quality Risk Management?
- Formal & Informal Risk Management Processes
- Primary Principles of QRM (ICH Q9)
- Secondary Principles of QRM
- The QRM Process — ICH Q9 Framework
- Risk Assessment — A Closer Look
- Risk Control & Risk Communication
- QRM Tools — ICH Q9 Recognised Methods
- FMEA — Failure Mode & Effects Analysis
- FMEA in Tablet Compression: Controlling Weight Variation
- The Risk Matrix — Visualising Risk
- QRM in Commercial Manufacturing
- HACCP Applied to Sterile Manufacturing — Contamination Control
- QRM in Product Development — Risk-Based Design
- Risk-Based Process Validation — Oral Solid Dosage Form
- QRM in Compliance Inspections
- QRM in Inspection Planning & Risk Assessment
- QRM in Dossier Review & Regulatory Submissions
- QRM in a GMP Inspection — Turning Risk into Compliance Confidence
- QRM in Practice — Common Mistakes to Avoid
Course Benefits
Fully compliant
This course follows the guidance of Annex 13 of the European Commission's GMP guidelines
Certified
All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from a database, re-sitting the exam doesn’t mean taking the same questions again and again.
Affordable
Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.
Time-saving
Our new administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training. Our reporting tools make it easy for administrators to check the progress of learners and identify areas for future training.
Reliable and trustworthy
This course was written by McCarthy Consultant Services Inc (Canadian specialists in regulatory work to support the global pharmaceutical, biotechnology, medical device, food, natural health products and cosmetic industries). You will also stay up to date with any legislative changes in GMP relating to IMPs as our training courses are constantly monitored, reviewed and updated.
Our Certified Customers
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