GAMP5 training (update) — 2nd edition

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1 day

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900

€ H.T including breaks and lunch

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Objectives of the internship

  • Understand and assimilate the new features of the new GAMP5 2nd edition version allowing an innovative approach to the validation of computerized and automated systems for GxP contexts.
  • Update that will allow you to assimilate and apply the GAMP 5 “critical thinking” approach and the “Data Integrity” requirements in an Agile and digital transformation context in the Pharma Industry.
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Teaching methods

  • Course based on the ISPE guidelines, GAMP5 2nd edition, the Data Integrity guidelines, the CSA guidance (draft) FDA CSV_for_Production_and_Quality_Systems
  • Presentation and delivery of a complete course material
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Staff concerned

  • All persons concerned with the validation of information and automation systems (ERP, GPAO, LIMS, LIMS, ELN, SCSE, WMS, MES, PLCs...): Information System and Automation Project Managers (functional and technical), User Project Managers, User Project Managers, Validation Managers, Validation Managers, Representatives of the Quality Assurance Department, integrators, editors, hosts...
  • Prerequisites: it is necessary to know the GAMP 5 first version
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Detailed program

  1. Reminder: key points: GAMP 5 methodology
  2. Overview of changes in V2: what is disappearing/what is evolving/what is new
  3. Review of the enhancements/additions of the 2nd edition:

    - “Critical thinking” approach

    - IT Infrastructure Management

    - Requirements specifications

    - GAMP risk approach and categories

    - Design review & traceability

    - Testing

    - Development in Agile mode

    - Management of software tools

    - Artificial intelligence and machine learning
  4. Examples/Exercises

    - Validation strategy and validation deliverables in Agile mode

    - Implementation of an optimized test strategy based on new FDA guidance
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Upcoming dates

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Paris (75)

01/04/2025

21/10/2025

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Lyon (69)

03/04/2025

23/10/2025

Register