Process Development Improvements Post-Pandemic
Dr. Blackwell, Founder and Principal Consultant at The Windshire Group, comments on learnings for process development as a result of meeting pandemic challenges. There are…
Back by Popular Demand, In this Encore Presentation, Dr. Blackwell, Principal Consultant, is on Expert Panel on Mapping the Transition from Drug Discovery to Development and Beyond
In this webcast, listen to Dr. James Blackwell, Founder and Principal Consultant of The Windshire Group, and a panel of leading industry experts discuss key…
Dr. Blackwell, Principal Consultant, is on Expert Panel on Mapping the Transition from Drug Discovery to Development and Beyond
In this webcast, listen to Dr. James Blackwell, Founder and Principal Consultant of The Windshire Group, and a panel of leading industry experts discuss key…
Validation Best Practices: Considerations
The following is an edited excerpt taken from The Windshire Group’s webcast Validation: Tried and True Success Lessons from the Front Lines Expert Panel Discussion-LIVE FREE…
Cell Therapy Process Manufacturing and Quality
The following is an excerpt taken from The Windshire Group’s webcast “Cell Therapy Expert Panel Discussion”: Dr. James Blackwell: It will not be business as usual. Sloppy…
What if I have a component that is a critical piece of the process, but there is only one supplier that can provide it, and they recently failed their supplier audit?
The following answer to the question “What if I have a component that is a critical piece of the process, but there is only one…
What are the areas of greatest risk for data integrity issues?
The following answer to the question "What are the areas of greatest risk for data integrity issues?" is taken from The Windshire Group’s webcast “GMP Data…
Computer System Validation- How Early in Product Development?
We are sometimes asked how early in development companies need to start worrying about computer system validation? While predicate rules do not directly answer this…
KBI Biopharma selects The Windshire Group’s and Simplyfeye’s ProcessPad™ continued process verification solution
BOSTON, MA--(Marketwired - May 24, 2017) - The Windshire Group, LLC and Simplyfeye Inc. are pleased to announce KBI Biopharma, Inc. will deploy ProcessPadtm for…
Begin with the End in Mind for Technology Transfer for Cell Therapy Processes
In this interview, Dr. James Blackwell, Founder and Principal Consultant of The Windshire Group discusses cell therapy technology transfer "Communication and taking the time to develop…