This article examines the myriad ways in which the failure to abide by even the simplest process and procedure regulations promulgated by the U.S. Food and Drug Administration can result in significant, even devastating, financial loss to a company.
Phillips Lytle special counsel George Hajduczok, Compliance Team RA/QA Consulting vice president Regina Fullin and Harvard Law School student Merve Ciplak contributed to this article.
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Since 2003, we have protected over 200 life science companies by assuring their quality systems, engineering validation programs and clinical studies consistently meet compliance standards. Our knowledge of FDA, ISO, EMA, Health Canada, and other regulating bodies secures you and your customers from costly regulatory and compliance mistakes. For more information visit: complianceteamllc.com.