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

Dillon,Ralph;Noferi,Joseph;Worden,Daniel;Arling,Edward;

Publication

Article

August 15, 2002

BioPharm International

BioPharm International-08-01-2002

Volume15

Issue 8

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

Author(s):

Ralph L. Dillon,Joseph F. Noferi, Esq.

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.

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Articles in this issue

Guest Editorial: Quality Agreements with Contract Laboratories

Survival Guide to FDA Inspections: Part 1, To Prepare or Not to Prepare, There Is No Question

Virus Inactivation in the 1990s ? and into the 21st Century: Part 2, Red Blood Cells and Platelets

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

Inside Washington: User Fee Program Seeks to Spur Biotech Development

Analytical Advances: Mapping Proteins – the 2-D Electrophoresis Issue

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