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  6. Office of Program and Regulatory Operations in Compliance
  1. CDER Offices and Divisions

Office of Program and Regulatory Operations in Compliance

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

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