FDA Law Blog: Do You Really Want to Be An Executive In An FDA-Regulated Company?:
"Appropriate to the forum, he focused on the industries regulated by FDA. The emphasis he gave to the requirements for settling civil and criminal cases brought against organizations gives sharp focus to the problem of doing business when governed by a law that operates with a malum prohibitum standard of liability, a law that permits findings of criminal guilt without proof of intent or guilty knowledge."
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You might also be interested in this course for cGMP leadership and top management:
Executive Session: What Leadership Needs to Know - GMP Training by SkillsPlus Intl Inc.
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