Executive Responsibility in Pharmaceutical Manufacturing


Lesson Code: RGM-500. The responsibilities of executive management in the pharmaceutical industry. Describes 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:

- Describe the role of executive management with regards to the regulation of pharmaceutical manufacturing

- Describe FDA's approach to inspecting the Quality System

- Describe the implications of non-compliance

- Describe the purpose of the FDA's regulatory oversight of pharmaceutical manufacturing

- Explain FDA 483s, Warning Letters and Consent Decrees

- Explain the purpose of the Quality System

- Explain the terms Quality Policy and Quality System