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.
Director, Investigations Branch,
FDA Office of Regulatory Affairs, Office of Biological Products Operations