Deborah Geyman became interested in pharma while still in high school; today, after working in the industry for three decades, she is the incoming ISPE North America South America Affiliate Council (NASAAC) Chair! We asked Deborah to share some of her experiences during her sixteen years with ISPE and her career in the industry she identified as her chosen vocation so early in life.
In the previous blog, GAMP® Support for Pragramtic Quality & Risk-Based Approaches, we saw how as part of the Case for Quality program US FDA CDRH (Center for Devices and...
“The grass is not always greener.” Have you ever been told that before? When I went to my long time mentor 13 years ago to let her know that I was resigning from our company those were the words she spoke to me. I took her words to heart, but still felt I was making the right decision at the time. Turns out, I did make the right move for my career at that time and I landed at an amazing...
As global regulators sharpen their focus on data integrity, issues have emerged around practices observed in operations that generate data used to make drug product decisions. One such practice is “testing into compliance”-- repeatedly analyzing a sample until a desired result is obtained, then reporting this value while ignoring all previous values. Regulators expect manufacturers...
