Validation of special procedures

Home > Validation of special procedures

Objectives

  • Understanding the specific EU and US regulatory requirements relative to procedure validation
  • Implementing a process validation based on the QI, QO, QP method
  • Controlling processes using a progress approach
  • Understanding the directing of processes to control their variability

Audience concerned

– Quality Assurance
– Quality Control
– Industrial development
– Maintenance/Metrology
– Production
– Qualification/Validation

Aim

Acquiring the basics

Programme summary

  1. Introduction and objectives
  2. Needs and standards assessment
  3. Connection with risk assessment – Defining test depths
  4. Integrating standards in a procedure and establishing a master validation plan
  5. Defining the documents connected to a validation dossier
  6. Defining the deliverables of validation dossier and drawing them up
  7. Good testing practices
  8. Statistical approach
  9. Conclusion

Prerequisites

There is no prerequisite for this training

Duration

2 days
14
-hour classroom attendance

Inscription

Download the registration form

Date des formations CaduCeum Academy

Ref : CAVPS

Informations and registration : academy@caduceum.co.uk