The author discusses the collection and evaluation of data part of FDA’s definition of process validation. Process validation is more than just running three consecutive batches under manufacturing ...

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 ...

FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice. FDA issued the guidance document Process Validation: General Principles ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

Process, Validation, Disclosure. Legal News and Analysis - USA - Telecommunications, Media & Technology - Conventus Law ...

Design of experiments enables engineers to demonstrate or understand a process while providing information required for achieving regulatory compliance. A valuable method for predicting process ...

A moldmaker said recently that it sometimes takes him up to eight months to validate a large, high-cavity medical mold. Maybe this surprises you, but it doesn’t surprise many OEMs in the medical and ...