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

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.