Food and Drug Administration(FDA) is encouraging pharmaceutical and biotech companies to submit regulatory information in electronic medium. This action reduces usage of large volumes of paper and help companies to exploit the advantages of using information technology in terms of portability, storage and retrieval. The electronic submissions have the same stringent regulations as in the case of paper submissions. Enrollment Limited.

Topics :

Testing(QA in IT):


• Environment and scope
• SDLC and importance of QA
• Different models of SDLC
• Manual testing
• Automated testing
• Tools for testing
• Testing methodologies
  
  Industry Specific:
  
  
• FDA guidelines
• FDA Regulations
• GxP Environment
• 21 CFR Part 11 Requirements
• Document Management
• Auditing and Conclusions

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