Skip to main content

American Conference Institute’s (ACI) 32nd annual FDA Boot Camp


Date: September 28, 2018

Time: 5:15AM - 12:00PM

Location: Boston, MA

Benjamin Zegarelli will speak on the Current Good Manufacturing Practices (“cGMPs”) for Drugs and Biologics, with the session focusing on examining cGMPs and the scope of their importance in pharmaceutical/biological product commercialization, factoring cGMPs into the scope of the FDA’s authority, exploring the scope of the FDA’s cGMP Initiative and the concept of “risk-based” cGMPs, conducting laboratory investigations in relation to cGMPs, understanding the influence of cGMPs in products litigation, and evaluating the costs and impact of enforcement actions. 


Benjamin advises pharmaceutical, medical device and biotech companies on the FDA regulatory process to identify the correct regulatory pathway, assisting with FDA communications and strategy.