Category: Podcast

How To Apply QbD to Drug Device Combination Products

Today, we invite Dr. Manfred Maeder of Novartis to share how Quality-by-Design is applied in the development of medical devices and drug device combination products. Previously, Dr. Lana Shiu of FDA shared the ongoing regulatory changes in drug device combination products. I recommend you listen to her presentation as...

Faster Drug Approvals with this underused QbD tool

“Does anyone not use QTPP?” was the original question asked to the ~21,500 scientists. Being a Quality-by-Design community, many claimed their organizations are using the essential element of QbD – the Quality Target Product Profile. Was it true?   However, data tells us otherwise. Today, Adria Tyndall share her research...

How to Implement QbD in Generics – Interview with Inna Ben-Anat

  Meet Inna Ben-Anat, Global QbD Director of Teva Pharmaceuticals. Inna is a key thought leader in Quality by Design for generics. I met Inna in person at the 2013 IFPAC conference  and we’ve been comrades in the QbD journey ever since.   I enjoy listening to folks who...