ABSTRACT
This chapter provides a comprehensive risk assessment and management strategy aimed at helping Food and Drug Administration (FDA)-regulated firms best prepare for the pre-approval inspection (PAI). It discusses how to make the most of the actual inspection while in progress, and design a post-inspection risk minimization plan that will secure credible and meaningful relationships with FDA officials throughout the submission review period and post-approval process. An institution or a pharmaceutical, medical device or biotech company, herein referred to as the sponsor, typically contracts a Contract research organization. Another important aspect of the GEM Plan is the role and responsibilities of the firm’s executive management. The chapter focuses on the GEM Plan as an important derivative of a comprehensive risk assessment methodology strategy; and as an initiative that should be launched prior to a PAI, and certainly if the firm’s management is aware of prevailing issues that are bound to surface during the inspection.
