Audits and Inspections

GXP audits and inspections are conducted to identify non-compliances, but also regulatory weaknesses and the potential for non-compliance. This course introduces students to GXP audits and inspections, including internal audits/self-inspections, external supplier evaluations, continuous evaluation and for cause audits, and Mock Pre-Approval Inspections (PAI). Students will develop the skills to manage regulatory compliance audits and FDA inspections and will learn how to survive an inspection when things are not going well.