A practical, case-based course on applying quality risk management. Revisit the principles and the QRM process, choose the right tool for the question, follow an FMEA step by step, and work through real-world cases such as a look-alike carton and a quiet supplier change, then learn how to review, communicate and build a risk-aware culture.

Manage changes the way modern regulators expect. This course places change management inside the Pharmaceutical Quality System (ICH Q10), clarifies what is in scope and how to handle grey areas, and shows how to classify changes using risk. You will follow the change process and its governance, carry out a structured impact assessment, plan the regulatory strategy for variations and post-approval changes (including ICH Q12), and decide what comparability and validation work is needed. Dedicated modules cover computerized systems, sector-specific considerations, and how to prove a change was effective and defend it during inspection. A final assessment and a certificate of completion are included.

Manage deviations from first detection to effective CAPA. Learn what a deviation is, types and categories, risk-based classification, the end-to-end deviation process, how to write a clear deviation report, investigation and root cause analysis, impact assessment and batch disposition, CAPA, trending and metrics, and the deviation findings inspectors raise most often.