Training & seminars
Module 7 – Good Aseptic Practices & Sterile Products (24 – 26 September 2018) – 3 day Course
24 September 2018 – 26 September 2018
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