TimeZone (UTC)
FDA Grand Rounds, "A discussion of technical and logistical considerations for examining FDA-Regulated products at international mail facilities using handheld and field-portable analytical devices," November 14, 2019, 12-1:00 PM EST Thursday, November 14, 2019 4:45:00 PM UTC - 6:15:00 PM UTC
About the Presentation: On October 26, 2017, the President of the United States declared a public health emergency to address the ongoing opioid crisis. In response, FDA vowed to help combat this epidemic by increasing the number of packages screened annually for dangerous goods at international mail facilities (IMFs) and express courier hubs (ECHs). FDA was then granted destruction authority at these locations for ‘articles of concern’, including unlawful FDA-regulated products that contain active pharmaceutical ingredients. Since the FDA’s Forensic Chemistry Center (FCC) has extensive experience analyzing violative FDA-regulated products, this laboratory was tasked with three main responsibilities to support FDA’s efforts regarding this initiative: 1) purchasing field-deployable instruments and developing methods to detect active pharmaceutical ingredients (APIs) in suspect samples, 2) participating in mail blitzes and other field operations to evaluate the performance of these methods on intercepted samples and 3) providing logistical and technical recommendations to senior FDA leadership regarding requirements of effective, efficient and robust IMF-based field laboratories. Successful completion of these three responsibilities will be followed by the implementation of field-based miniature laboratories at IMFs with the ability to provide analytical results to support the destruction of dangerous FDA-regulated products on site so that these products do not reach the US supply chain. This presentation will focus on details regarding FCC’s responsibilities for this endeavor. See here: https://www.fda.gov/grandrounds Speaker Adam Lanzarotta, PhD Presented by: Adam Lanzarotta, PhD Chemist, Office of Medical Products, Tobacco, and Specialty Laboratory Operations Office of Regulatory Affairs If you've never used Adobe Connect, get a quick overview: http://www.adobe.com/products/adobeconnect.html |