Janet Woodcock is the new acting FDA Commissioner – why QbD scientists are hopeful
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COVID-19 Vaccines FDA Advisory Committee Meetings – Pfizer & Moderna
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Ask Questions: Upcoming Interview with Anurag Rathore
Submit your burning QbD or PAT questions! This week, I am thrilled to interview Dr. Anurag Rathore, the co-author of Quality by Design for Biopharmaceuticals: Principles and Case Studies. We’ll talk about Anurag’s personal journey and his book in QbD. Dr. Anurag S. Rathore is currently a professor at...
Dr. Janet Woodcock (CDER, FDA) Speech at ISPE 2013
Dr. Janet Woodcock is the director of CDER, FDA and oversees 4000 people and 10000 drugs. At ISPE 2013, Dr. Woodcock began with the statement –“Industry QbD adoption was successful. but QbD submissions were a mixed success. Culture of quality is not there yet.” She also openly talked about...
QbD Works – Quality by Design for Biotech, Pharmaceutical and Medical Devices.
QbDWorks is a resource website dedicated to Quality by Design for Biotech, Pharmaceutical and Medical Devices. Hello, I’m Sun Kim, PhD. I’ve been working inside (and outside) the Biotech, Medical Device field for 10 years with the goal of innovating how we develop products (drug, therapy, medical device, equipment, and service...