FDA Auditing Computerized Systems and Part 11

 

Monday, Tuesday and Wednesday (8:30 a.m. - 5:30 p.m.)

 

Course Content:

 

  • FDA and Computerized System Validation

    • Which validation deliverables the FDA expects and what they should contain

    • Why so many compliance dollars and resources are wasted on ineffective or inadequate validation

    • How the FDA defines a systems risk, plus mitigation strategies you can deploy

 

  • FDA Guidance on Part 11 Scope and Application

    • Part 11 rules for electronic records and signatures

    • Paper vs. electronic? Ensuring electronic data correlates to paper records

    • Why data integrity is critical with or without Part 11

    • Current status of Part 11 – revisions, rewrite or abandonment?

 

  • Computerized System Development Model and Methods

    • Proven techniques for developing compliant software

    • Change control and configuration management

    • Data and information resources

 

  • Key Principles and Techniques for Computerized System Validation

    • Five pillars required for effective CSV, including: system management and monitoring, system change management, vendor management and CSV methodology management

    • Keys to maintaining your systems in a validated state

    • How to identify, document and report computerized system validation deviations

    • Ensuring audit trails and secure data access and transfer

    • Applying CSV to various types of systems, including legacy systems

    • Evaluating software vendor compliance claims

 

  • Regulatory Enforcement – Overview and Recent Trends

    • Top validation errors cited in FDA enforcement actions

    • Proactive steps to avoid CSV and Part 11 Form 483s and warning letters

 

  • Workshop: Exercises and Simulated Inspection of Computerized System Development

    • How to prepare for the FDA inspector – using a simulated inspection with real-world scenarios

    • Learn how to apply effective auditing techniques

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