Introduction to Quality Risk Assessment (QRA)

Description

Course Title: Introduction to Quality Risk Assessment (QRA)

Course Description:
This foundational course introduces students and professionals to the principles, methodologies, and applications of Quality Risk Assessment (QRA) within regulated industries, particularly pharmaceuticals, biotechnology, and medical devices. Participants will explore the systematic process of identifying, analyzing, and mitigating risks that may impact product quality, patient safety, and regulatory compliance.

Through a blend of theoretical instruction and real-world case studies, the course covers key concepts such as risk identification, risk analysis, risk evaluation, and risk control. Tools and techniques like Failure Mode and Effects Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), and risk matrices will be discussed in detail. Emphasis is placed on aligning risk management practices with international standards and guidelines, including ICH Q9.

By the end of the course, learners will gain a practical understanding of how to apply QRA in quality systems, support decision-making, and foster a risk-based approach to quality management.

Learning Outcomes:

• Understand the fundamentals of Quality Risk Assessment and its role in quality management systems.

• Identify and apply key risk assessment tools and techniques.

• Evaluate and prioritize risks to ensure product quality and patient safety.

• Integrate QRA principles into regulatory and compliance frameworks.

• Interpret and implement ICH Q9 guidelines and other industry standards.

Target Audience:
This course is ideal for quality assurance professionals, regulatory affairs personnel, manufacturing and operations staff, and others working in life sciences or other highly regulated environments seeking to build or enhance their risk management capabilities.