The same qualified individuals who daily craft regulatory solutions for both QA Edge’s small
    and Fortune 500 clients are actively involved in developing and presenting riveting,
    content-rich seminars and workshops.

    The flexibility and focus of these training sessions and their supporting materials can be
    customized to meet specific company requirements. Seminars are conveniently presented
    on-site at client locations providing added benefit by reducing travel time and cost.

    Training Programs

    Agenda

    Three-Day Risk-Based Approach to Computer Validation

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    • Day 1:
      • Regulatory Background and Predicate Rules
      • Scope and Latest Status of 21 CFR Part 11
      • Overview of Computer Validation
      • Risk-Based Approach
        • Industry Standards
        • Class Exercise
    • Day 2:
      • Writing Better User Requirements
        • URS Process
        • Requirements Management
        • Generic User Requirements for Part 11 Technical Controls
      • Effective System Testing
        • Test Planning and Management
        • Test Case Development for System Acceptance, IQ/OQ
        • Use of Testing Tools
        • Classic Testing Mistakes
        • Generic Test Scripts for Part 11 Technical Controls
    • Day 3:
      • Production Controls and Infrastructure Qualification
      • Writing the Validation Report
      • Change Control & Re-Validation
      • A Risk-Based Approach for Legacy System Compliance Remediation
        • Unique efficient methods using the “Fit for Purpose” approach
      • Summary Q&A

    One-Day Risk-Based Approach to Computer Validation.

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    • Background on FDA, Part 11, and Computer Validation
    • Risk Assessment/Management
      • Risk Exercise

    One-Day Auditing Software Suppliers

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    • Setting Audit Objectives
    • Reviewing Evidence of Control (covering design, testing and customer support)
    • Report & Follow-up

    A one-hour or three-hour Overview of Computer Validation

    (held over the web or on-site)

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    • Background on FDA, Part 11, and Computer Validation

Computer Compliance Made Easy