During the COVID-19 pandemic, pharmaceutical research goals and deadlines remained unchanged; thus, the need to continue operations as usual required creative solutions to the travel restrictions that lasted throughout the pandemic In response to these challenges, remote audits, including the audit of bioanalytical data at the sponsor or a CRO such as Alturas Analytics, Inc., have become a useful tool for the FDA. Initially, these reviews were considered remote inspections; however, they quickly morphed into what is now termed remote regulatory assessments. Alturas was the subject of one of the initial remote inspections in 2020 and we also hosted a remote regulatory assessment more recently (in 2022). In the remote inspection, a 482 was issued at the outset and the inspectors followed the pattern of an onsite audit fairly closely. The inspection was very laborious for both the inspectors and the staff at Alturas due to the FDA processes and Alturas’ not yet optimized remote audit practices. Alturas’s 2022 remote regulatory assessment was a much different experience as both sides had become more familiar with remote auditing. In the time between the two FDA audits, Alturas hosted at least one remote customer audit per month and put considerable effort into developing best practices for how to provide the best customer service experience for our sponsors. The internal effort at Alturas combined with updates to the FDA’s processes made the remote regulatory assessment in 2022 a much more streamlined and efficient process. The current format for remote regulatory assessments have made them a valuable tool that allows the FDA access to data without the added expense and time of traveling to each site, while being less disruptive to daily activities at the site being audited. In this presentation, details from the remote assessments will be discussed as well as tips and tricks for hosting a successful remote regulatory assessment based upon Alturas’ experiences.
About the Presenter
Dr. Jennifer Zimmer is the Laboratory Director at Alturas Analytics, Inc. and has been working in the field of bioanalysis for over 20 years. She received her B.A. degree in English and Zoology from the University of Idaho and her Ph.D. in Pharmacology from the University of Colorado Health Sciences Center, working in Dr. Robert Murphy’s laboratory on the leukotriene lipid mediator pathway. Her post-doctoral experience in Dr. Richard Smith’s laboratory focused on using metabolomics to elucidate disease pathways and to discover novel biomarker targets.
Dr. Zimmer is responsible for the overall operation of the Alturas Analytics laboratory. She has experience with FTICR, TOF, ion trap and quadrupole instrumentation. She has utilized these instruments for quantitation as well as structure elucidation using HPLC-MS/MS and HPLC-MSn. She oversees the scientific staff and ensures that client deliverables are met while working laterally with the Alturas Analytics, Inc. QAU in order to maintain laboratory compliance with all procedures and regulations. Dr. Zimmer is an active participant in the Global CRO Council (GCC) and a member of the American Society for Mass Spectrometry.
