About the Webinar
In December 2021, U.S. FDA published a draft guidance on the topic of Inspection of Injectable Products for Visible Particulates. Visible particles in injectable products is a high priority area for FDA due to the potential safety risks. This is also a high compliance risk area for many injectable manufacturers. This presentation will cover the main topics presented in this draft guidance and discuss some of the important nuances with performing visual inspection. The presentation will offer insight into FDA’s recommendation that manufacturers develop and implement a holistic, risk-based approach to visible particulate control that incorporates product development, manufacturing controls, visual inspection techniques, particulate identification, investigation, and corrective actions designed to assess, correct, and prevent the risk of visible particulate contamination.
DANIEL J. ROBERTS
DANIEL ROBERTS evaluates and assesses pharmaceutical quality systems and specializes in detecting and remediating data integrity concerns and evaluating compliant automated manufacturing processes and related computerized systems. Dan has over 20 years of government regulatory and pharmaceutical/biopharmaceutical industry experience. He was an FDA investigator for eight years, including two years as the primary point of contact for conducting
pharmaceutical inspections at the FDA India office located at the U.S. Embassy in New Delhi. Prior to joining the FDA, Dan worked in the biopharmaceutical / biotechnology industry for eight years, specializing in quality control analysis for large molecule biotherapeutics.
CHRISTOPHER FANELLI
CHRISTOPHER FANELLI is a former FDA enforcement lawyer and a partner in Sidley’s Food, Drug and Medical Device Compliance and Enforcement group. First in government as an Associate Chief Counsel for Enforcement in FDA’s Office of the Chief Counsel and now in private practice, Chris focuses his practice on compliance with GMP and GLP requirements.