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E-Learning Module: Computerized Systems Validation
CompuPharma Ltd
This CompuPharma 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 fundamentals of computer validation and the validation process. Also introduces the FDA's 21 CFR Part 11 ruling on electronic records and signatures.
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 and explain the terms IQ, OQ and PQ in CSV
- Define change control and explain its importance in CSV
- Define Validation Policy, Validation Master Plan, Validation Protocol and Validation Report
- Describe how IQ, OQ and PQ relate to DS, FS and URS
- Describe the five categories of Computerized Systems
- Explain System Life Cycle, URS, FS and DS
- Explain the principle of computerized systems validation (CSV)
- Explain the purpose of the 21 CFR Part 11 regulation
- Explain what is meant by risk analysis
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: Introduction to 21 CFR Part 11
E-Learning Module: Method Validation Parameters
E-Learning Module: Laboratory Equipment Qualification
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