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 21 CFR 210 and 211, or Eudralex Volume 4. The Module explains who regulates the pharmaceutical industry, how new drugs are approved, types of regulatory inspections, and the role of employees in inspections.
Objectives:
- Describe the FDA regulatory inspection procedure - Describe the purpose and work of regulatory agencies - Distinguish between the different types of FDA regulatory inspections - Explain the possible outcomes of FDA inspections - Name the three main regulatory agencies
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.
This module is extracted from the E-Learning Course: Essential GMP for Finished Dose Operators (Certified).
