Validation of equipment is a procedure that is used for checking that a system meets requirements and specifications and that it fulfils its intended purpose. A successful validated equipment shows, that it is able to create reproducible results.
In order to perform validation activities, there is a need to cooperate with the operations department. In times of a pandemic, it is necessary however that the production of medical device companies is stable and in many times able to produce high quantities of needed devices.
There are therefore conflicting objectives: The continuation of production, which means contacts between different departments, which should actually be avoided vs. further validation of the equipment. In this course, you will learn tools that help to deal with this conflict and that allow you to continue the validation activities under these difficult conditions.
Offer an overview of the principal tools and method to guarantee the right standard of validation.