Validation ensures that a part will operate correctly in end-user applications. Design validation is the task of testing a part or a system adequately to ensure that all parts or systems manufactured ...

This Design validation 4 hour session will discuss how to write validation protocol and determine acceptance criteria. It will also explain the systematic approach to validate analytical procedures.

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...