What should firm think and how should they act if faced with signing a consent decree or if trying to avoid signing one? This presentation will address elements of consent decrees for drug, biological, and dietary supplement manufacturers and for compounding pharmacies and the roles of expert third parties. Detailed assessments; reporting requirements; extensive remediation/corrective action plans; verifications that corrective actions are effective and the periodic audits required over a 3-5 year period will be discussed. Learn how to think, act, organize, change, communicate and resolve a decree and/or how to avoid a consent decree. Understand the elements of a consent decree and how to act if under one and/or how to avoid one.