Aim: This subject is designed to facilitate the development of knowledge and practical skills in the assessment of special risksassociated with the manufacture of sterile pharmaceuticals and to develop and evaluate strategies and plans that will ensure acceptable sterility assurance levels.

Day 1       AM ►Assess the regulatory requirements for aseptic manufacturing processes in order to provide recommendations for their application to

ensure compliance

PM ►Evaluate the processing and compliance risks associated with aseptic processing and terminal sterilization

Day 2       AM ►Critically evaluate strategies for bioburden control

PM ►Evaluate the available processes for sterilisation and depyrogenation

Day 3        AM ►Prepare risk based environmental assessments PM ►Understand the updates to ISO14644-1 and -2:2015