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About Me

About me:  I have almost 19 years in the U.S. working in the GMP field.  Mostly validation and QC

I started out in a small contract chemistry laboratory doing wet and analytical methods.  These included USB, BP, EP, and JP methods.  Instrumentation included HPLC, GC, AA, TOC, and IC.  Wet methods included USP titanium dioxide assay, arsenic, and lead.

Facilities I have worked in include: laboratories, Grade A injectable filling lines, medical device filling lines, transdermal delivery solutions,  vaccines, immuno-oncology product, and a compounding pharmacy.

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The Injectable Filling Facility From Hell

I know this is a long story, but it is a look inside the “ Walmart of Pharmaceuticals. ” How the everyday products used in hospitals get made...or don’t. "[10/365] Injected" by dissolved is licensed under CC BY-NC-SA 2.0 My second GMP laboratory took me to a sterile injectable manufacturing facility. It was a slight pay increase and I had moved near another site the company. I hope that I might be able to transfer closer to home eventually. I was sorely mistaken. It was the worst experience laboratory work experience of my life. But that's another post. Fast forward six years at the facility was to become my worst validation experience of my life. I was forced into my choice because my two viable opportunities for work were working at this injectable facility close to home or work in downtown Boston in the winter. I chose the former. I also needed to be close to home to go to a training class for a very good cause/family every weekend. When I told my ...

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"I'd Like to Help Us Get Through An FDA Audit, But It's Tax Season."

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