This session will be presented by FDA’s Office of Regulatory Affairs, Office of Biological Product Operations investigations and operations staff. Discussion will include FDA’s current regulatory oversight to include mission critical work, remote regulatory assessments under Section 704(a)(4) and prioritized domestic inspections. Best practices and recommendations will be presented on what to expect after receipt of an FDA Inspection Records Request, as well as how to prepare for and what to expect before, during and after onsite mission critical inspections to promote inspectional readiness.
To view Spanish or English subtitles, click the "CC" box in the video player. Para ver subtítulos en español o inglés, haga clic en el cuadro "CC" en el reproductor de video.
Describe FDA’s OBPO organizational structure, and best practices for communicating with OBPO.
Discuss a high-level overview of an FDA inspection, to include how to prepare for inspections and what to expect before, during and after the inspection; to include any oversight of convalescent plasma.
Describe FDA’s Office of Regulatory Affairs, Office of Biological Products Operations (OBPO) current inspectional activities, to include remote regulatory assessments, pre-announcements and safety measures, during the current public health emergency.
Director, Investigations Branch,
FDA Office of Regulatory Affairs, Office of Biological Products Operations
All relevant financial relationships have been mitigated. By completing the evaluation, you are attesting to watching the presentation in its entirety. A certificate will be immediately provided after submission.
AM21-72: FDA Office of Regulatory Affairs Oversight during a Public Health Emergency Evaluation