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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 M. Zegarelli is a Mintz Associate who counsels clients on compliance and regulatory issues, with a focus on FDA regulations. Benjamin advises clients in the pharmaceutical, medical device, and biotech industries. He provides counsel on research approval, sales, and contract negotiations.