Ajay Pazhayattil is associate director of technical operations at Apotex, Inc.
Lessons from FDA 483s and cGMP Inspection Data
Production and process controls, organization and personnel were the top problems found, while packaging and labeling citations increased in 2017 and 2018.
A Novel Metric for Continuous Improvement During Stage Three
How statistical methods and novel indices can be used to monitor and benchmark variability, to guide continuous improvement programs.