Understanding the USP and FDA Functions in the Pharmaceutical Industry 2016

Key Topics

• Absence of enforcement power for use of USP methods and regulatory status of the USP as a communication tool
• Function of the USP to share established methodology to support the growth of the generic pharmaceutical industry
• Inherent inefficiencies in the USP monograph creation process and associated liabilities created by a retrospective perspective design
• Conflicts in the charters of the USP and the FDA
• Illustrate the FDA emphasis on integrating new technology into pharmaceutical operations to improve safety and quality

Who should Attend

Attendees from:

• Users in the generic pharmaceutical industry, including API manufacturers, contract laboratories and pharmaceutical manufacturers
• Generic pharmaceutical company QC Directors, QC Managers, QC Chemists, ARD Directors, ARD Managers, ARD Chemists
• Any users currently relying on the use of USP monographs without modification