Defining and examining IT changes introduced by the ISO 13485 standard

Home > Defining and examining IT changes introduced by the ISO 13485 standard

Objectives

  • Understanding the new IT constraints included in the 2016 version of the standard, and incorporating them in ongoing project management
  • Understanding the different phases necessary for the validation of IT systems (V Cycle)
  • Conducting a validation project for a critical IT system as per standard requirements
  • Drawing up a validation dossier

Audience concerned

– All those already aware of IT systems
– IT Managers/Validation Managers
– Project managers, engineers
– Regulatory affairs/quality managers

Aim

Acquiring fundamentals/further development

Programme summary

  1. Introduction and aims of IT system validation
  2. Normative and regulatory context, revising the standard
  3. Identification of new constraints
  4. Presentation of the V Cycle
  5. Validation Procedure and Workshop
  6. Audit Trails and Data Integrity
  7. Quality Documentation (related operational procedures and methods)
  8. Conclusion

Prerequisites

Have an awareness of IT Systems.

Duration

1 day
7-hour classroom attendance

Inscription

Download the registration form

Date des formations CaduCeum Academy

Ref : CADATA

Informations and registration : academy@caduceum.co.uk