Validation of computerized systems

Validation of computerized systems

Details

  • Start date: 29 November 2022
  • Start time: 10:00 (Kyiv)
  • Finish date: 30 November 2022
  • Finish time: 13:15 (Kyiv)
  • Duration: 2 days, 6 hours
  • Break: yes
  • Category: Production (GMP)
  • Format: Streaming
  • Online broadcast available: yes
  • Venue: Online
  • Language class: Русский
  • Cost for connecting to the webinar of one computer (participant): $212.

    VAT is not paid.

    $106 discounted price:

    – for each subsequent participant from one organization;

    – students, subject to the presentation of a student card.

    $148 discounted price:

    – clients of the Conformity Assessment Body UKRMEDCERT LLC and GXP UMEDCER LLC.

     

    The price includes: information service, video recording of the webinar, a set of training materials and a certificate in pdf format.

     

    Target audience: Authorized persons, quality directors, persons responsible for the implementation and operation of the quality management system, qualification and validation specialists.

     

    Webinar program

    1. Regulatory framework.

    Review of existing normative documents.

    2. Terms and definitions.

    Review of applied profile terminology and definitions.

    3. Annex 11 GMP EU (overview).

    4. General guidelines, risk management, personnel, vendors and service providers, validation, data, data storage, printouts, auditing, change and configuration management, periodic assessment, security, incident management, electronic signature, batch release, business continuity, archiving.

    5. IT infrastructure.

    Interpretation of the concept and a brief overview.

    6. Categories of computerized systems.

    Category overview.

    7. Necessary documentation.

    User Requirements Specification (URS), project, Functional Specification (FS), Technical Specification (TS), Configuration Specification (CS).

    8. Stages of validation.

    Consideration of necessary validation steps.

    9. Validation documentation (Validation Master Plan (VMP), validation protocols and IQ/OQ/PQ validation reports).

    10. Basic list of tests.

    11. Conclusion.