Lesson Code: RGM-1200. Overview of the regulatory responsibilities of executive management in the pharmaceutical manufacturing industry. This e-Lesson explains FDA and legal requirements and the corporate and personal consequences of non-compliance.
After taking this e-Lesson, you will be able to:
Keywords: Compliance, Consent Decree, Criminal Prosecution, Debarment, Executive Management, FDA, FDA 483, Food Drug and Cosmetic Act, Good Manufacturing Practice (GMP), Personal Responsibility, Quality Policy, Quality System