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Mastering Computerized System Validation; A Step-by-Step Guide to Ensuring Compliance and Managing Risk

Mastering Computerized System Validation; A Step-by-Step Guide to Ensuring Compliance and Managing Risk

$199.00
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Mastering Computerized System Validation: A Step-by-Step Guide to Ensuring Compliance and Managing Risk



Course Overview

This comprehensive course is designed to provide participants with a thorough understanding of computerized system validation, ensuring compliance with regulatory requirements and managing risk. Upon completion, participants will receive a certificate issued by The Art of Service.



Course Features

  • Interactive and engaging learning experience
  • Comprehensive and personalized course content
  • Up-to-date and practical information with real-world applications
  • High-quality content developed by expert instructors
  • Certification upon completion
  • Flexible learning options with user-friendly and mobile-accessible platform
  • Community-driven with actionable insights and hands-on projects
  • Bite-sized lessons with lifetime access and gamification
  • Progress tracking to ensure successful completion


Course Outline

Module 1: Introduction to Computerized System Validation

  • Definition and importance of computerized system validation
  • Regulatory requirements and industry standards
  • Overview of the validation process
  • Roles and responsibilities in validation

Module 2: Planning and Preparation for Validation

  • Validation strategy and planning
  • Risk assessment and management
  • System definition and boundaries
  • Validation team roles and responsibilities

Module 3: System Development and Implementation

  • System design and development
  • System testing and verification
  • System implementation and deployment
  • System maintenance and support

Module 4: Validation Testing and Verification

  • Test planning and execution
  • Test case development and review
  • Test results analysis and reporting
  • Defect management and resolution

Module 5: Validation Reporting and Documentation

  • Validation report development and review
  • Validation documentation and record-keeping
  • Regulatory submission and approval
  • Maintenance and update of validation documentation

Module 6: Ongoing Validation and Maintenance

  • Ongoing validation and re-validation
  • System changes and updates
  • Validation of system retirement and decommissioning
  • Continuous improvement and quality management

Module 7: Risk Management and Compliance

  • Risk assessment and mitigation
  • Compliance with regulatory requirements
  • Audit and inspection preparation
  • Corrective and preventive action (CAPA)

Module 8: Specialized Validation Topics

  • Cloud computing and virtualization
  • Mobile applications and devices
  • Artificial intelligence and machine learning
  • Internet of Things (IoT) and connected devices

Module 9: Validation Tools and Techniques

  • Validation software and tools
  • Automated testing and validation
  • Lean and agile validation methodologies
  • Validation metrics and benchmarking

Module 10: Validation Best Practices and Lessons Learned

  • Best practices for validation success
  • Common pitfalls and mistakes to avoid
  • Lessons learned from case studies and real-world examples
  • Future trends and directions in validation


Certificate of Completion

Upon successful completion of the course, participants will receive a certificate issued by The Art of Service, demonstrating their expertise and knowledge in computerized system validation.

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