Quality and Development by Design (QDbD) vs. Quality by Design (QbD)
Date: 05 March 2019
Time: 15:00 - 16:00
Tutors: Dr Andrei Zlota
This FREE to attend webinar will be presented by Dr Andrei Zlota, The Zlota Company, LLC.
3.00 pm (UK); 4.00 pm (Central European); 10.00 am (East Coast USA)
Resistance to change is well documented, and constitutes a preferred topic of discussion in organizational development workshops. There are many dimensions to the difficulty of implementing change, however our focus in this brief webinar will be the practical scientific, regulatory and business aspects of QbD implementation challenges. Over 15 years ago, when the FDA announced its QbD initiative, one of the key QbD benefits presented was regulatory flexibility. However, several other important advantages were identified in the practice of QbD, most importantly our reliable capability of developing robust processes and methods. As a result, there are two dimensions to QbD implementation: regulatory flexibility and good development, the latter sometimes referred to as “Development by Design”. In this talk we will briefly assess the status of both dimensions, clarifying that they have not been equally realized, and that such discrepancy should not deter us from continuing to work towards the realization of regulatory flexibility while continuing to improve our ability to design robust processes and methods.