FDA Validation 2011 - Quality by Design ? An FDA initiative to Aid companies in the Development of Products and Reduce the Regulatory Burden

This Quality by Design training will explain what exactly QbD is and how to implement it in your development program. It will explain FDA expectations and the return on your investment with respect to improved operations and reduced regulatory burden.

QbD is a FDA driven program that has had the added benefit of building trust between the agency and industry. With the added openness and trust, the agency is reaching out to help reduce the regulatory burden on the producer with simpler submissions, reduced frequency of inspections and less complex regulatory hurdles to tackle.

In this Webinar, you will learn the origins and rationale for the QbD program, exactly what Quality by Design is and how it might be applied to your operations. With these investments of effort, you will learn what you must provide to the agency and the benefits you might glean from the effort. You will also appreciate why your other submissions have not met the requirements of QbD previously. These benefits work equally well for established products that are currently on the market and those that you plan to commercialize in the future.