Course Overview:

Quality Risk Management (QRM) provides a structured, science-driven way to evaluate and control risks that may impact patient safety, product quality, or regulatory compliance. Regulators increasingly expect QRM to be embedded throughout the Quality Management System, using both formal and informal tools aligned with ICH Q9 principles—risk assessment, risk control, risk review, communication, and acceptance of residual risk.

This advanced, practical training uses real case studies to help participants confidently apply QRM concepts to quality system issues and manufacturing processes. Through interactive exercises, attendees will gain hands-on experience selecting appropriate tools, conducting risk assessments, and interpreting outcomes that support robust decision-making.

Course Outline:

Day 1 — QRM in Quality & Compliance

Quality systems rely on well-informed, evidence-based decisions. Whether addressing customer complaints, deviations, audit findings, or CAPA, a structured risk assessment process strengthens compliance and supports consistent product quality. Day 1 focuses on applying QRM tools within key GxP processes and improving the quality of compliance-related decisions.

Topics include:

• QRM framework and core concepts
• How risk supports GMP compliance and decision-making
• Applying risk assessments within key quality systems:
o Audits
o Change Control
o Complaints & Adverse Events
o Deviations & Non-conformances
o CAPA

Day 2 — QRM for Manufacturing & Process Risk

QRM has become integral to pharmaceutical manufacturing since its adoption into GMPs. Day 2 provides a practical understanding of when and how to use the right tools, ensuring risk assessments add real operational value. Participants will learn how to evaluate process risks, identify controls, and build risk-based justification for manufacturing decisions.

Topics include:

• Understanding process risks and critical factors
• Overview of GMP expectations for process risk assessments
• Selecting from the QRM toolbox: choosing the right tool for the problem
• Practical application of key tools:
o Preliminary Hazard Analysis (PHA)
o Hazard Analysis & Critical Control Points (HACCP)
o Failure Mode & Effects Analysis (FMEA)

Participants

This course is suitable for personnel new to risk assessment as well as experienced QRM practitioners. It is especially valuable for individuals involved in quality systems, regulatory compliance, manufacturing operations, or anyone responsible for evaluating and managing risks that impact product quality and patient safety.