Project & Quality Training International

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System Qualification Validation according to GAMP & Data Integrity

In many industries validation is defined as the documented evidence that a procedure, process and activity will consistently lead to the expected results. It often contains the commissioning, qualification & validation (CQV) of systems (as equipment, instrument, computer, utility, etc.). It is a requirement for Good Manufacturing Practices (GMP) and other GxP regulated industries.

Qualification Validation is according to FDA's "Establishing Documented Evidence that provides a high degree of assurance that will consistently producing a process specifies a product meeting its pre-determined specifications and quality attributes." (FDA 1987). A properly designed system will ensure a high level of assurance that each step, process and change is well assessed before the implementation takes place.

Who should attend this training

This training is specially designed for Commissioning Qualification Validation (CQV) staff, Quality Controllers, engineers, ICTer, project managers, process engineers and others who are interested in Commissioning Qualification Validation according to GAMP®.

If non-Dutch students participate, the training will be in English language.

General information

  • The student will receive two weeks training for an email training and location details
  • The student will receive a certificate after the training
  • Lunch and refreshments during the training included
  • The student receives at the beginning of the training a binder which includes the printed slides of the presentation

Trainers

Price

  • € 795,00 per student (excluding VAT)

Registration

You can register for this training using the tab 'Training schedule'.

For information please contact René van Opstal, phone +31 (0) 6 53630698 or email This email address is being protected from spambots. You need JavaScript enabled to view it.