Risk Management
Science Based Approach A Risk-based approach to validation, as advocated by the FDA, is beneficially being adopted by many of the major pharmaceutical companies who can focus valuable resources where the risk is higher.
This course looks at a scalable Science-based approach to Risk Management and discusses the recommended requirements of a Risk Management process and gives examples of processes successfully adopted.
Course talks about standard methods used across the industry such as FTA – Fault Tree Analisys, and FMEA - Failure Mode and Effects Analysis.
