Annex 15 - Qualification and Validation

Annex 15 – Qualification and Validation


This Annex covers the requirements for the validation of GMP facilities, systems and processes.


Annex 15 – Qualification and Validation

This interactive e-Learning module provides the participant with an understanding of the GMP regulations relating to validation and qualification. This module is suitable for validation, engineering and quality personnel who work within GMP facilities.

This module covers the requirements for:

  • organisation and planning of validation activities
  • the Validation Master Plan
  • definitions of terminology commonly used in validation
  • the requirements for cleaning validation
  • the basic V model for the validation life cycle


After successful completion of each course in the bundle the trainee will have the option of printing or saving a personalised training certificate that meets regulatory GMP requirements.


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