Qualification/Validation according to Annex 15 of good manufacturing practices

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Objectives

  • Understanding the steps of the Qualification and Validation process
  • Understanding the new Qualification and Validation regulatory requirements

Audience concerned

Manufacturers/subcontractors in the healthcare sector:
– Regulatory affairs/quality managers
– Department Heads: Production, R&D
– Project Managers, software engineers

Aim

Acquiring the basics

Programme summary

  1. Introduction and objectives
  2. Context and Scope of application
  3. Quality risk management
  4. Organisation and planning of the Qualification and Validation process
  5. Documentation
  6. Qualification process phases for equipments, installations, utilities and systems
  7. Re-qualification
  8. Procedure validation
  9. Transport verification
  10. Packaging validation
  11. Utilities qualification
  12. Test methods validation
  13. Cleaning validation
  14. Change control
  15. Conclusion

Prerequisites

There is no prerequisite for this training.

Duration

1 day
7-hour classroom attendance

Inscription

Download the registration form

Date des formations CaduCeum Academy

Ref : CAQV

Informations and registration : academy@caduceum.co.uk