FDA's rigorous level of oversight was perceived ... The main benefits of the QbR system are to assure product quality through design and performance-based specifications, facilitate continuous ...
Regulators are increasingly interested in the quality-by-design approach ... Conformia's Cooperative Research and Development Study with the FDA.
The clearance covers design modifications and labeling updates ... including areas that have not been part of the FDA's recent inspections with the intent of making our quality system truly best in ...