E-Learning Module: Introduction to 21 CFR Part 11

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. Explains 21 CFR Part 11 in detail and its impact on regulated industries. Particular emphasis on electronic records and signatures (ERES).

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:

- Compare open and closed systems
- Define audit trail and time stamp
- Define electronic records and electronic signatures
- Distinguish between biometric and non-biometric signatures and list their Part 11 requirements
- Explain "linking" of electronic records and signatures
- Explain the purpose of operational, authority and device checks
- Explain the purpose of the 21 CFR Part 11 regulation
- Explain what is meant by a hybrid system
- List the Part 11 compliance requirements for closed and open systems
- Summarize the general action points required for achieving Part 11 compliance

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

Also available

• E-Learning Course: IT Use and Analytical Validation (Certified)
• E-Learning Module: IT Use in Regulated Industries
• E-Learning Module: Computerized Systems Validation
• E-Learning Module: Method Validation Parameters
• E-Learning Module: Laboratory Equipment Qualification

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