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.
About the Presenter
With over 20 years in Quality Assurance, David Schumacher, RQAP-GLP since 2004, oversees the Alturas Analytics Quality Assurance Program. David is an experienced Quality Assurance Professional in FDA regulated environments and auditor in numerous analytical techniques. His emphasis is in bioanalytical (LC−MS/MS and ligand binding) and formulation assays.
With a strong laboratory background, David is known for his GLP auditor skills specializing in analytical sciences. His attention to detail and contributions to the Alturas QA Team add significant value to Alturas Analytics. He is considered by his colleagues to be a mentor and a source of regulatory insights. In the community on a volunteer basis, David provides safety communications for a number of special events as a licensed Ham radio operator to prepare for actual disasters where other forms of communication may not be available.