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E-Learning Module: GXP Introduction
CompuPharma Ltd
This CompuPharma GXP Module is ideal for people who are new or existing employees of the Pharmaceutical or Medical Device sector and who are required to work according to GMP. The Module describes how pharmaceutical products are developed and approved, how the pharmaceutical industry is regulated, and the background, function and implementation of GXPs (GLP, GCP, and GMP).
Objectives:
- Define GXP and why it is necessary
- Describe the consequences of non-compliance with GXPs
- Describe the functions of the FDA
- Describe the history of GXP
- Explain GLP, GCP and GMP in terms of their functions, history, regulations and requirements
- Explain what the pharmaceutical industry does and what stages are required before a drug can be placed on the market
- Explain where GXPs are found
- Name three regulatory agencies and list their main functions
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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