Validation and verification of processing methods and biobanking

Processing methods are being applied in research laboratories, biobank laboratories or technological platform laboratories. Validation of such methods is an important undertaking to ensure the fitness for purpose of the biological specimens that are the output of these methods.

This course will explain the concept of a processing method, and of its validation or verification. It will go through different approaches that can be followed, the steps that can be taken, the statistical tools and the acceptance criteria to perform method validation, as well as the required documentation. The concept of exploratory methods will also be approached and the risks that are concomitant to a non-validated processing method will be illustrated with different examples.

The course will largely follow the recommendations of the international Standard ISO21899:2020 but will present application of the concepts to concrete laboratory situations.

Speaker: Dr. Fay Betsou (Institut Pasteur)

*EACCME accreditation was only available for live event