As the COVID-19 pandemic spread across the USA in early 2020, many facilities had to reduce operations, preventing auditors from traveling to customer sites. Alturas Analytics developed processes to permit auditors to conduct their inspections remotely. Additionally, Alturas Analytics was one of the first companies to be inspected remotely by the FDA in April. This presentation will present tips for a simple and positive remote audit experience and describe the process employed by the FDA to successfully complete a remote regulatory inspection.

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.