Overview
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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Speakers
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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JONATHAN GIL serves as Corporate Counsel in Pfizer Inc’s Legal Division, in the Global Supply Legal Group. Jonathan supports Pfizer’s global sterile injectable manufacturing and supply chain network on compliance with regulatory requirements, including GoodManufacturing Practice (GMP), Quality System Regulations (QSR), controlled substance regulations and state licensing. Jonathan also supports GMP and Good Clinical Practice inspections and other interactions with regulators, including US FDA and counterpart ex-US regulators. Prior to joining Pfizer, Jonathan worked at US FDA, where he held roles as Regulatory Counsel in the office tasked with implementation of PDUFA, BSUFA, and GDUFA, and as Regulatory Counsel in CDER’s Office of Compliance, Immediate Office. During his time at FDA, Jonathan also completed an assignment as a Special Assistant United States Attorney at the US Attorney’s Office for the District of Columbia, where he prosecuted criminal cases.
CATHY L. BURGESS is a partner at the law firm of Alston & Bird, LLP in Washington, DC, and serves as the co-chair of the firm’s FDA Practice. Her practice focuses primarily on regulatory compliance, product and supply chain risk management, enforcement, and policy matters related to CGMP and QSR regulation of global manufacturers. Ms. Burgess provides strategic counseling, conducts internal investigations and special audits related to FDA compliance, and assists clients in designing compliance programs, internal audit programs, and other risk mitigation strategies. She is recognized as a leading practitioner for life sciences, food and beverage law, and in the area of pharmaceutical and medical products regulation.Virtual Learning FAQ
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