392104 Analysis and Interpretation of a Process Risk Assessment

Wednesday, November 19, 2014: 10:00 AM
Crystal Ballroom C/D (Hilton Atlanta)
Praveen Sharma1, Ben Lane2, Theo Martinot2 and Alfredo Castro2, (1)Chemical Engineering, Infinity Pharmaceuticals, Cambridge, MA, (2)Infinity Pharmaceuticals, Cambridge, MA

A case study will be presented on a late stage quality risk assessment carried out on a manufacturing process using Failure Mode and Effects Analysis (FMEA). The case study will focus on demonstrating methods and techniques that can be used to analyze the results of a risk assessment to extract the most learnings and value from the exercise. In particular, categorization of risk reduction actions and data visualization are leveraged to better understand the current risk associated with a process and determine the level of risk that may need to be accepted moving forwards. The outcome is a comprehensive framework for making process changes geared towards reducing risk on scale up.

Extended Abstract: File Not Uploaded
See more of this Session: Reducing Risk during Technology Transfer
See more of this Group/Topical: Process Development Division