Who We Are
The Office of Program and Regulatory Operations (OPRO) provides expertise in leading and managing compliance projects, by utilizing innovative and efficient project management skills, tools, and techniques to shield the public from poor quality, unsafe and ineffective drugs.
What We Do
- Lead and manage operational infrastructure support for the Office of Compliance (OC) relating to project management of compliance-specific program areas such as drug manufacturing, supply chain security, pharmacy compounding, unapproved drugs, controlled correspondence, and informatics oversight.
- Engage in quality management activities to continuously improve processes that support work quality and efficiency within OC.
- Collaborate with OC offices and other FDA components on cross-functional projects to ensure high-functioning teaming environments are developed and timelines and deliverables are met.
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
