Stability Data Analysis Product Case Study
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…
8 Biggest Mistakes in Conducting Deviation Nonconformance Investigations-Part II
This post, The 8 Biggest Mistakes In Conducting Deviation Nonconformance Investigations-Part II, discusses an additional 6 mistakes industry professionals need to avoid. 3. Not getting…
Pitfalls to Avoid For Determining a Product’s Shelf Life Q&A
In Pitfalls to Avoid For Determining a Product’s Shelf Life Q&A, The Windshire Group’s Chief Stability Scientist discusses Excel trending and the amount of time…
8 Biggest Mistakes in Conducting Deviation Nonconformance Investigations-Part I
This post, the 8 Biggest Mistakes in Conducting Deviation Nonconformance Investigations-Part I discusses the first two mistakes industry professionals need to avoid. Deviation investigations are…
What Does Chemistry Manufacturing and Controls Mean?
At The Windshire Group, Chemistry Manufacturing and Controls (CMC) includes allied activities throughout the product lifecycle... While I believe the term, Chemistry, Manufacturing and Controls (CMC) …