QbD: Past, Present and Future by Anurag Rathore
I am thrilled to have Dr. Anurag Rathore share his QbD journey with our QbDWorks community. This is a followup to the previous post. This is a part of QbDWorks interview series where we interview the thought leaders of Quality by Design to discuss what works and what doesn’t in QbD....
QbD Framework – in 2 Minutes (for Scientists)
When I began my QbD journey, I was confused by the jargons that FDA or ICH used (or created) in their guidelines. After some time I understood it. But now I had to explain it to those who are new to Quality by Design. They were unimpressed due to...
Speaking
Many of you have asked for my presentation slides. In the spirit of sharing, you can download them here. Below are some QbD conferences that I have presented at. (Disclaimer: I am not affiliated with the organizations below.) Please email me Here for speaking or workshop inquiries. Latest: IFPAC 2016...
3 Reasons Why QbD Risk Assessment is Key + 3 Tips
Have you led or supported a QbD project? Then you will agree that Risk Assessment is a critical piece — like the small hinge that a big door (QbD) revolves around. The activity may seem trivial but has major implications. In fact, QbD revolves around risk assessment. If you...
QbD Dying Prematurely? Use This QbD Metric
Boss: “I haven’t seen the results yet. There are 5 other high-priority programs. How can we justify your time training scientists on QbD? Can we even measure the success this year?” QbD Manager: Its been only 6 months…I can see R&D scientists beginning to use DOE (Design of Experiments)...
QbR 2014 Vision of ONDQA FDA
I apologize for the delayed posting. I was out of commission with a severe flu for a week. Now I’m back with energy and enthusiasm to share. One exciting announcement: In a few weeks, QbDWorks will begin an Audio Series which contain personal interviews with QbD experts in our...
QbD and PAT Topics at IFPAC 2014
Which QbD or PAT topics interest you? I’ll be attending the IFPAC 2014 Conference in Washington DC. IFPAC began in 1987 and is relatively a small community of Regulatory Agencies, Manufacturers and Researchers focusing on Process Analytical Technology (PAT), Quality by Design (QbD), Process Understanding & Control, and Real-Time Analytics. Sharmista Chatterjee, Ph.D....
Risk Assessment for QbD: Why FMEA Fails
If you tried a FMEA-based risk assessment for QbD, you will be familiar with the following story. Picture yourself and 4 scientists starting a meeting in a conference room at 4pm. Scenario: Fighting over a rating of 3 versus 4 Project Manager: Let’s continue our Risk Assessment using FMEA. Today...
Practical Tips on QbD from FDA, MHRA & EMA
This post is packed with practical tips on QbD (Quality-by-Design) and other topics, straight from the global regulatory agencies. Officials from Regulatory Agencies (FDA, EMA, MHRA) opened up the floor to the industry for questions. Since the scope was beyond QbD, I bolded the QbD-relevant questions and responses from...
QbD Success and Challenges: ONDQA Implementation
Dr. Christine Moore shared her perspectives on the current status of QbD. The talk was titled: ONDQA Implementation, QBD: the success and remaining challenges. I am sharing my raw notes from her talk. Again, I will edit the article further after I return from my trip. I encourage you...