The U.S. Food and Drug Administration issued a guidance on voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, compounded, or held, and at drug facilities.
FDA Issues Guidance on Remote Inspections
FDA Remote Inspections
Read More
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.
Read More