Recorded July 14, 2020 | On-Demand Webinar
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.