Program Overview

This program equips participants with the knowledge and skills to apply Risk Management as a strategic quality assurance tool across pharmaceutical and life sciences operations. Anchored on ICH Q9 and ISO 31000 guidelines, the course covers essential tools such as FMEA, FTA, HACCP, and HAZOP, with practical applications in QA, QC, manufacturing, and R&D. Through real-life case studies—spanning cleaning validation, supplier qualification, and recall prevention—participants will gain insights into regulatory expectations, common pitfalls, and best practices. Interactive simulations and workshops reinforce hands-on learning, enabling participants to design robust risk control strategies, build effective risk registers, and integrate risk-based thinking into continuous improvement and Quality by Design (QbD) frameworks.