After great anticipation, in April 2021 FDA issued the guidance, “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency.” This guidance describes FDA’s process during the remainder of the COVID-19 public health emergency for conducting voluntary remote interactive evaluations at medical product manufacturing, processing, packing, or holding facilities; facilities covered under FDA’s bioresearch monitoring program; and outsourcing facilities. In May 2021, FDA also released its “Resiliency Roadmap for FDA Inspectional Oversight,” summarizing FDA’s inspectional activities during COVID-19 and the agency’s future inspection-related priorities. How will FDA determine whether a company is eligible for a remote interactive evaluation? How is a remote interactive evaluation different from an in-person inspection? What should facilities expect and how should they prepare? Speakers will address these issues and look to the future for how FDA could use virtual inspections beyond the pandemic to expedite reviews and approvals.

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Jonathan Gil, Sr. Corporate Counsel, Pfizer Inc.
Rachel Harrington, Consumer Safety Officer, Medical Products & Tobacco Operations, ORA, FDA
Moderated by Cathy L. Burgess, Partner, Alston & Bird LLP and Member, FDLI Board of Directors


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