Program Overview
This program provides a deep-dive into Risk-Based Quality Management Systems (QMS), connecting regulatory frameworks like ICH Q9 and ISO 31000 with operational quality practices. Through a mix of conceptual understanding, situational analysis, real-world case studies, and interactive exercises, participants will learn how to apply risk-based thinking across QMS pillars such as CAPA, deviations, supplier qualification, and audits. Delivered by an industry expert with over 25 years of experience, the program equips professionals with the tools, frameworks, and strategies needed to embed risk-based approaches into daily operations, ensuring compliance, resilience, and continuous improvement.
Features
- Apply ICH Q9 and ISO 31000 principles to build a robust, risk-based QMS
- Use advanced risk assessment tools (FMEA, HACCP, Fault Tree Analysis) for decision-making
- Link risk-based quality approaches to CAPA, audits, supplier qualification, and operational excellence
- Design strategies to embed risk-based thinking into organizational culture and continuous improvement
Target audiences
- Regulatory Affairs and Quality Assurance Teams
- Operations Teams
- Risk managers
- QA/QC Professionals
- Cross-functional team leads
Curriculum
- 5 Sections
- 19 Lessons
- 1 Day
Expand all sectionsCollapse all sections
- Foundations of Risk-Based Quality Management4
- Risk Identification & Assessment within QMS4
- Operational Quality through Risk-Based Thinking3
- 3.1Linking risk management to Quality Systems (QMS pillars – CAPA, change control, deviations, audits)
- 3.2Role of risk-based approaches in decision-making & compliance assurance
- 3.3Case based learning: Risk-based deviation management, Risk prioritization in cleaning validation, Risk-based supplier qualification
- Embedding Risk into Organizational Culture & QMS4
- Strategic Integration & Continuous Improvement4
Instructor
