ORA and CDER officials provided an update on the agency’s Concept of Operations initiative in a Thursday panel discussion at the FDLI’s Enforcement Litigation and Compliance Conference in Washington D.C., detailing the next steps in implementing the concept.
Paula Katz, director of CDER’s Manufacturing Quality Guidance and Policy Staff, said agency officials are now drafting SOPs for the initiative related to inspection and surveillance activities. They also are training CDER and ORA staff on ConOps workflows and associated roles, responsibilities, processes and procedures.
Alonza Cruse, director of ORA’s Office of Pharmaceutical Quality Operations, said ConOps will make reviews and inspections happen concurrently. This marks an effort by the FDA to lessen delays and inconsistency caused by the “lack of alignment” between CDER and ORA during pre-approval inspections and post-market enforcement.