Following up on last week’s successful “Law Over Lunch” session with FDLI, CEO Jack Garvey will be presenting a live webinar titled, “State of FDA Medical Product Manufacturer Inspections During and After COVID-19” next week, July 14th, at 2pm Eastern.
In May 2020, FDA announced that for the duration of the COVID-19 pandemic, the agency would continue its March 2020 postponement of domestic and foreign routine surveillance inspections, while considering mission-critical inspections on a case-by-case basis. In lieu of in-person inspections, the agency will be utilizing alternative means, such as record review and virtual inspections, as well as relying on self-policing requirements such as cGMPs. This webinar will address tools the agency is using to ensure industry compliance during the COVID-19 pandemic and legal authority and limitations underlying these tools. The panelists will also discuss logistical and legal challenges facing industry in the context of virtual inspections, and ways for industry to respond to these challenges.
Kalah Auchincloss, SVP, Regulatory Compliance & Deputy General Counsel, Greenleaf Health, Inc.
Jack C. Garvey, Chief Executive Officer, Compliance Architects LLC
Moderated by Neeraj Pai, Partner, Sidley Austin LLP