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Interactively learn and apply requirements in validating Computer System Applications. By concentrating on information systems and instruction on how to meet requirements of CFR 21, Part 11 Electronic Records, Electronic Signatures, the course includes how to test systems security, data integrity, backup and recovery. Hands-on exercises allow students to use validation principles through assessments to determine the level of validation required, writing validation plans, protocols, executing protocols, and analyzing results. Case studies and simulated validation deviations allow participants to experience real-life situations while honing problem-solving skills.
This course may be taught at any location.
This 2 day, 16 hour course covers the following topics:
- Types of Computer Application Validation
- GMPs and Regulatory Requirements
- Industry Guidance Documents and Documentation requirements
- Risk Assessments and Determining what to test
- Creating validation documentation
- Handling discrepancies or deviations during testing
Upon successful completion participants will be able to:
- Understand regulatory requirements related to information systems
- Assess the levels of validation needed for computer system applications
- Determine key functions within computer systems
- Demonstrate proficiency in handling validation deviations
- Prepare and respond to requirements of validation auditors
This course is designed for individuals seeking industry training related to validation work done for computer system applications and personnel responsible for implementing and using regulated computer systems in the biotechnology and biopharmaceutical sector.