After its finalisation, the Guideline ICH Q9 “Quality Risk Management” was implemented in the EU, the U.S. and Japan.  In the course of implementing ICH Q9, the risk-based approach increasingly gained in importance. Before that, it was often the case that processes were defined, implemented and documented to the latest detail.  Now, based on risk assessments, more flexibility is possible, allowing implementing and controlling processes more efficiently. Decisions can be made based on evaluated risks. QRM permits scientifically substantiated decision making based on a previously assessed risk.

Unfortunately, many companies limit their whole QRM system only to the implementation of the FMEA method. But it is much more than this and QRM can really support the pharmaceutical industry in improving their processes and performance.

This two-day course is designed for members of staff in pharmaceutical, biopharmaceutical and API industry’s production and quality units, who establish, manage and improve quality risk management systems.