Quality By Design and Process Validation

February 12, 2014 by

The FDA has made significant progress in implementing the concepts of “Quality by Design” (QbD) into pre-market processes. The QbD concept is that quality should be built into a product through a deep understanding of the product, both how it’s developed and how it’s manufactured. A comprehensive understanding of the risks involved in manufacturing a product and how best to mitigate those risks is also required.The QbD initiative attempts to provide guidance on pharmaceutical development to facilitate design of products and processes with  maximum  efficacy, safety profile and product manufacturability.  QbD  forms the basis of process validation activities conducted by pharmaceutical manufacturers in validating their product manufacturing processes.

Join us on February 26, 2014 at 1pm EST for a review of “Quality by Design” concepts and discussion on its relevance to process validation. During our discussion we will have an opportunity to see a demonstration of Validator, a software product that facilitates the adherence to the QbD principles and best practices in process validation.


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