Office of Program and Regulatory Operations | Pharmaceutical Quality
Who We Are
The Office of Program and Regulatory Operations (OPRO), part of CDER’s super Office of Pharmaceutical Quality, leads and manages operational infrastructure for the Office of Compliance (OC) relating to project management and process management.
What We Do
- Lead OC’s project management program
- Provide operational and regulatory expertise for cross-functional initiatives and projects across OC and involving other Agency components
- Develop and implement internal procedures and innovative processes to optimize work quality and efficiency
- Manage OC’s controlled correspondence operations
- Manage information technology governance across OC.
Organization
- Program and Regulatory Operations Staff I
- Program and Regulatory Operations Staff II
- Program and Regulatory Operations Staff III
Contact Us
Email: CDERCompliance@fda.hhs.gov
Phone: 301-796-3100
Office of Compliance
10903 New Hampshire Avenue
Bldg. 51, Room 5278
Silver Spring, MD 20993-0002
Resources
- Office of Pharmaceutical Quality
- Pharmaceutical Quality Resources
- Office of Pharmaceutical Quality Reports
- Annual
- Report on the State of Pharmaceutical Quality
- White Paper: FDA Pharmaceutical Quality Oversight