The ConOps agreement outlines responsibilities for CDER and ORA and the workflow for Pre-Approval, Post-Approval, Surveillance, and For-Cause Inspections and evaluations – for domestic and international facilities. CDER and ORA began developing processes to begin to operationalize these workflows in the fall of 2017. FDA has begun updating appropriate documents such as Compliance Programs (CPs, formerly known as Compliance Program Guidance Manuals), the Investigations Operations Manual (IOM), and the Regulatory Procedures Manual (RPM).
