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E-Learning Module: Executive Responsibility in Pharmaceutical Manufacturing
CompuPharma Ltd
This CompuPharma GMP Module is ideal for both new and existing employees in the Pharmaceutical Industry, who are required to work according to the regulations of 21CFR 210 and 211, or Eudralex Volume 4. The Module explains the responsibilities of executive management in the FDA regulated pharmaceutical industry. Describes the legal requirements and the corporate and personal consequences of non-compliance.
Objectives:
- Define Executive Management
- Describe FDA's approach to inspecting the Quality System
- Describe the personal implications of non-compliance
- Describe the purpose and function of FDA
- Explain FDA 483s, Warning Letters and Consent Decrees
- Explain the purpose of the Quality System
- Explain the terms Quality Policy and Quality System
This is a self paced highly visual interactive e-Learning Module, with a full audio voiceover, which can be taken online. It has a 16 question multiple choice Assessment which the Trainee can perform once they have completed the module. For the Certified option, a hard copy certificate is mailed to the Trainee, once they have achieved a score of 100% in their Assessment.
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