Setting Limits - EMA/Risk-MaPP Approaches Applying Health-Based Limits to determine if Dedicated Facilities are required

This session will review the changing regulations in regards to managing the risk of cross-contamination and the impact on multi-product facilities. An overview of the health-based limit setting process as proposed by the EMA and as laid out in ISPE's Risk-MaPP as well as an assessment on how this will impact global regulations will be provided. Discussion of the proposed EU GMP updates for managing the risk of cross-contamination. Participants will understand the limit setting procedures, be able to compare the EMA proposed limit setting procedures with ISPE's Risk-MAPP and determine when dedicated facilities are required.