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…
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…
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…
BOSTON, MA--(Marketwired - May 24, 2017) - The Windshire Group, LLC and Simplyfeye Inc. are pleased to announce KBI Biopharma, Inc. will deploy ProcessPadtm for…
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…
One of the most dreaded problems in large scale biomanufacturing is contamination events. These events negatively impact an organization in many ways: lost batches and…
Expedited Approval Pathways Increase Risk and Burden on CMC and Manufacturing: risk reduction strategies include earned value analysis and partnering. As discussed in a recent…
ICH Q10 Guidance and Process Validation Guidance published by FDA in 2011 emphasizes both routine process monitoring and Continued Process Verification (CPV) as a key…
The client was a small, virtual company. They had one person responsible for CMC activities. Their initial request was, "can you just take a look…
The client knew that they needed to conduct statistical-based stability analysis for their product. They had stability data for 25 lots of drug product…