FDA returned on September 1 for inspections at full throttle. They have a new mandate. They will inspect. How can you be prepared?

This discussion will focus on the minimum requirements that must be met to ensure compliance and how to overcome your fear of an inspection. Topics will include the roles of management, quality, manufacturing, maintenance, purchasing, and validation. Who’s in charge and what do regulatory inspectors expect from you and your team? Regulatory inspectors are taught to ask two questions and make one statement. What are these? Why do they ask these questions and make this statement? What responses are given and what responses should be given. What requirements must be met and why? This presentation is a fun, learning opportunity to prepare yourself for your upcoming inspection. Put your FDA hats on and come join the inspection party. Those that have heard this presentation have provided very positive feedback.