Making Regulatory Compliance a Core Process: Director and Officer Liability Exposure

by Joseph F. Noferi, Edward R. Arling, and Ralph H. Dillon, Pharmacia GS API Biopharma, global supply, and Daniel E. Worden, Worden Enterprises FDA is no longer complacent, punishing noncompliant companies with puny fines, those small slaps at the financial bottom line. FDA?s thunder now includes multimillion dollar fines, permanent injunctions, and prison sentences for senior executives. Companies that emerge as winners in today?s environment are those that treat compliance and risk management with the same flawless planning and execution that they use for their business plans and their financial investments.