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.
Course Number: BIOL-40356
Credit: 0.00 unit(s)
Related Certificate Programs: Quality Assurance and Control