Executive Responsibility in Pharmaceutical Manufacturing


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.


  • Category: Regulatory GMP for Management

Description

After taking this e-Lesson, you will be able to:

  • Explain the relationship between a pharma company's Executive Management and the FDA 
  • Describe the purpose and function of the FDA
  • Describe 3 types of FDA inspection and the purpose of each
  • Explain FDA 483s, Warning Letters, and Consent Decrees
  • Explain the terms 'Quality Policy' and 'Quality System'
  • Describe the characteristics of a properly functioning Quality System
  • Explain why documentation is so important in a Quality System

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