This presentation will focus on recent Janssen plans for the application of an S88 recipe based approach, encompassing an end to end execution model, from the laboratories, through clinical manufacturing, into commercial production. The S88 standard is used as a ...
Year: 2013
We are living longer than ever before. We are healthier than ever before. We have more doctors, hospitals, medicines and health products than ever before. But, we have a problem with continuing to make these improvements. It still takes too ...
Year: 2013
Discussion Regarding FDA Guidance for Industry on Process Validation: General Principles and Practices, January 2011, Current Good Manufacturing Practices (CGMP) Revision ...
Year: 2013
MES and Electronic Batch Recording (EBR) have become critical business applications for most large and mid-size pharmaceutical manufacturers. The initial implementations of these technologies focused on translating the paper batch record to something filled out on a computer (Paper on ...
Year: 2013
Genentech Process Technical Development has come a long way in the past 5 years. Migrating from local on the floor trending on dedicated workstations to desktop and terminal server based Processbook displays was a big step forward. However, Coresight represents ...
Year: 2013