Program Overview
This program provides participants with practical expertise in applying risk management frameworks to quality systems, enabling proactive control and compliance. Anchored in ICH Q9 and ISO 31000 guidelines, it explores tools such as FMEA, FTA, HACCP, and HAZOP, with case studies from QA, QC, manufacturing, and R&D. Delivered by a senior industry expert with 25+ years of experience, the course blends conceptual grounding, situational awareness, regulatory insights, and hands-on exercises like FMEA simulations and building risk registers. Participants will gain actionable strategies to integrate risk management into Quality by Design (QbD) and continuous improvement, ensuring resilience against compliance failures, recalls, and audit gaps.
Features
- Apply structured risk management tools (FMEA, HACCP, HAZOP) across functions to assure quality.
- Anticipate, assess, and mitigate risks in product, process, and supplier management.
- Build and maintain a risk register to support audit readiness and regulatory compliance.
- Integrate risk management with QbD and continuous improvement for long-term business value.
Target audiences
- QA/QC Professionals
- R&D Professionals
- Manufacturing Professionals
- Regulatory Affairs and Quality Assurance Teams
Curriculum
- 4 Sections
- 16 Lessons
- 1 Day
Expand all sectionsCollapse all sections
- Foundations of Risk Management in Quality4
- Risk Management Tools & Methodologies4
- Real-Life Applications & Case Studies4
- Interactive Workshop & Exercises4
Instructor
