compliance news
FDA Issues Draft Guidance for Remote Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities
FDA Issues Guidance on Remote Inspections
FDA Remote Inspections
Best Practices for Remote Audits
The coronavirus (COVID-19) pandemic has forced biotechnology, pharmaceutical, and medical device companies to suspend normal operations and transition to new and innovative ways of doing business. With current restrictions on international and domestic travel, traditional on-site audits are not possible, exposing organizations to increased compliance risk. In some cases, remote audits may provide a viable alternative to ensure continued compliance and oversight. This article will summarize best practices for selecting and conducting remote internal and external audits.