GxP Computerized Systems Validation

• Define ‘computerized system’.
• Explain the purpose of computerized system validation.
• Explain the purpose of the 21 CFR Part 11 regulation.
• Define ‘risk’ as it relates to computerized systems.
• Describe how software in computerized systems is categorized.
• Explain the purpose of incorporating CSV into the system life cycle approach.
• Describe the activities involved in the project phase of CSV.
• Explain why risk management must be done throughout the operating phase of a computerized system.

Learner Benefits:

• Robust Understanding of Computerized Systems in Regulated Environments: Develop a foundational comprehension of computerized systems, including their role and impact in GxP regulated environments.

• Facilitate Compliance with Industry Regulations: Learn practical methods for validating systems in line with crucial regulations such as 21 CFR Part 11 and understand the consequences of non-compliance, including regulatory audits and potential penalties.

• Proficiency in CSV Risk Management and Lifecycle Approaches: Acquire the skills to evaluate risks associated with computerized systems and integrate validation into the system’s lifecycle, ensuring consistent compliance and operational integrity.

• Practical Knowledge of CSV Implementation and Documentation: Gain insights into planning, specifying, configuring, and verifying computerized systems. Recognize the importance of complete and accurate documentation to ensure system reliability and regulatory proof during inspections.

    Animations
   Voice Over
    Knowledge Checks
    Assessments
   SCORM/AICC compatible
    Full Screen