COVID-19 disrupted normal operations across the entire pharmaceutical business spectrum requiring most to find innovative ways to maintain operations. Reduced hours, work from home environments and limited travel were just a few of the adjustments that had to be made in order to maintain employee safety. Reduced travel had a significant impact upon the ability to conduct supplier and regulatory audits. One of those areas was conducting supplier audits of critical functions. Instead of in-person visits to facilities, supplier audits resorted to technology including the use of video and on-line file sharing. As the economy slowly returns to normal, businesses and the FDA are evaluating whether the remote audit needs to go the way of the dodo bird or should remain a tool for auditors. This presentation will describe why remote audits are probably here to stay for both business and regulatory agencies.
Performing a successful remote audit.
Understanding the FDA Remote Audit Guidance Document