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Why Design Validation is More Than Testing: How do we validate our validation?

A session by Michael Drues
President, Vascular Sciences

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About this talk

Validation usually involves a lot of testing. But what tests do we do? What tests do we not do? When can we use standard tests and when do we have to develop new ones? More importantly, how do we know we’re doing the right tests? If a test is “required” must we do it? In other words, how do we validate our validation? And how do we defend our validation when FDA criticizes it? This presentation will use the case study approach to take a broad approach to validation in an interactive fashion including:

• What are we required to validate and how/when do we do it?

• How do we validate our validation? How do we defend our validation when FDA questions it?

• What are the consequences if our validation is wrong?

• If we change our device, when and how do we revalidate?

• What are the validation challenges for the future?