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Validation should not be regarded as a once-only activity, but rather as an ongoing process. Thanks to equipment qualification, the correct functioning of equipment must be approved on a regular base.

Internationally accepted regulations state that method validation should be as comprehensive as necessary to fulfill the requirements of the given application. This means that a validation process must be adapted to the particular procedure. It is not necessary to specify all the performance parameters, but only those relevant to the procedure that has to be validated. It is the analyst’s responsibility to identify the specific performance and method parameters and to design an appropriate procedure for the validation of the method.

In some cases, time can be saved by using:

  • standards (ASTM, DIN, ISO, etc.) or
  • methods evaluated as part of an interlaboratory test

In analytical laboratories, most analyses are nowadays performed using computerized measurement systems. A validation process can be used to demonstrate fitness for purpose of the system before starting the experiments. The seminar presents the basic concepts step by step. The focus is on in-house method validation. The nine validation steps are described in detail using suitable examples.

In this presentation, we will discuss the basic principles of validation, from equipment qualification and computerized system validation through to analytical method validation.

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