E-Learning Module: IT Use in Regulated Industries

Skillpad

This Skillpad Module is ideal for people who work in the API, Biotech or Pharmaceutical sectors and are governed by the Rules of the FDA's 21 CFR11 and the Eudralex Annex 11. The Module explains the basics of Information Technology and Good Computer Practice and looks at how IT is used in regulated industries.

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.

Objectives:

- Define computer network, LAN and WAN
- Define Internet, e-mail, intranet and World Wide Web
- Describe the importance of computer security in regulated industries
- Describe the various uses of IT in regulated industries
- Distinguish between computer software and computer hardware
- Explain what is meant by the term "Information Technology"
- List and describe the rules for good computer practice

This module is extracted from the E-Learning Course: IT Use and Analytical Validation.

Also available

• E-Learning Course: Advanced GMP for Medical Device Operators (Certified)
• E-Learning Course: Advanced GMP for API/Bulk Operator (Certified)
• E-Learning Course: Advanced GMP for Finished Dose Operators (Certified)
• E-Learning Course: Advanced GMP for Solid Dose Operators (Certified)
• E-Learning Course: IT Use and Analytical Validation (Certified)
• E-Learning Module: Computerized Systems Validation
• E-Learning Module: Introduction to 21 CFR Part 11
• E-Learning Module: Method Validation Parameters
• E-Learning Module: Laboratory Equipment Qualification

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