Industry has experienced a large increase in the number of Good Manufacturing Practice (GMP) related inspections of their manufacturing sites around the world. It is acknowledged that this is partly due to the increasing global complexity of pharmaceutical supply chains and consequent dissemination of regulatory oversight to multiple worldwide inspections. This session will discuss how emerging regulatory requirements put additional hurdles on resource management and facilitate a more effective use and oversight of companies' efficiencies, and enforcement policies as driven by pharmaceutical quality systems in inspectorates and industry.

Learning Objectives:
Discuss foreign inspection programs
Identify how to facilitate risk-based approaches based on ICH Q9
Describe resource management of inspections Discuss pharmaceutical quality systems element on auditing.