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T. J K. Patient Expert

Bridgewater, New Jersey
Mr. Kuhn was trained as an analytical chemist at SUNY Geneseo. He began his career in the... Full Bio
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FDA FY 2010 Inspectional Observation Summaries by T. J K. Patient ExpertHealth Maven Posted in: Blog Posts in General Medicine The FDA has recently updated their published  483 inspection results here.  This is really a great resource as it breaks the findings down by regulation and how often it ... Read on »
Ingredients of All-Natural Blueberries by T. J K. Patient ExpertHealth Maven Posted in: Blog Posts in General Medicine tjkuhn : As a scientist, I find it troubling when people go on about not wanting chemicals in their food. *There’s chemicals in everything….You are made of che ... Read on »
Computer System Validation (CSV) Audit Mindmap by T. J K. Patient ExpertHealth Maven Posted in: Blog Posts in General Medicine As a break from writing, I finished the first electronic version of my CSV Audit Mindmap . The intent is for it to be a mental tickler during an audit. Rather than 10-20 p ... Read on »
ALCOA – A standard for evidence by T. J K. Patient ExpertHealth Maven Posted in: Blog Posts in General Medicine Reblogged from T. J. Kuhn | GxP Zone: In my current role (Clinical Quality Assurance), I support groups that are involved in validating electronic systems for ... Read on »
Mobile Devices in Medicine by T. J K. Patient ExpertHealth Maven Posted in: Blog Posts in General Medicine There’s been a lot of interest in expanding the use of mobile electronic devices as a part of medical treatment. They’ve been in use in clinical trials (for Patient Report ... Read on »
More Bad News for Travel by T. J K. Patient ExpertHealth Maven Posted in: Blog Posts in General Medicine As reported by the BBC , British Airways flight crews will begin their strike soon. Read on »
Continental to Cancel Flights to Avoid Fines by T. J K. Patient ExpertHealth Maven Posted in: Blog Posts in General Medicine As a business traveler, this is troubling news: Due to the government’s knee-jerk reaction, the cost of travel will be rising sharply. Now, I hate getting trapped on ... Read on »
New Drug Development – 1.5 Billion Dollars by T. J K. Patient ExpertHealth Maven Posted in: Blog Posts in General Medicine I was sad (though not surprised) to hear of JnJ’s pending layoffs. I have friends who work there. However, the thing that really caught my attention in this article is t ... Read on »
Defending Pharma by T. J K. Patient ExpertHealth Maven Posted in: Blog Posts in General Medicine As all of the discussion on Healthcare reform comes to a head, I think it warrants some comments from me regarding “The Greed of Pharma”.  Let me start by saying that Ph ... Read on »
SQA Abstract 2 – Building a Better Way by T. J K. Patient ExpertHealth Maven Posted in: Blog Posts in General Medicine And here’s the second abstract I submitted. This one is with colleagues from Data Management and Systems Validation (IT). It should be a really good session. Again, fing ... Read on »
SQA Abstract – Impact of eSystems, etc. by T. J K. Patient ExpertHealth Maven Posted in: Blog Posts in General Medicine I’ve submitted this abstract to the SQA for their annual meeting in April and am really hoping it is accepted. A very similar one that I posted last year was not….but th ... Read on »
Fundamentals of Quality by T. J K. Patient ExpertHealth Maven Posted in: Blog Posts in General Medicine I’ve gotten some questions of late that have had me thinking about the core of what I do; fundamental questions as to what it is and why. This is a good thing and I feel ... Read on »
SQA by T. J K. Patient ExpertHealth Maven Posted in: Blog Posts in General Medicine The Society of Quality Assurance is a great professional society for those of us working in Quality Assurance, etc. in Pharma and related industries. I just received em ... Read on »
Not a real blogger? by T. J K. Patient ExpertHealth Maven Posted in: Blog Posts in General Medicine When I first started this blog up, I was flattered that Shel Israel picked up on it. He was excited to find a real Pharma blogger. He actually wanted to interview me for ... Read on »
NYC Half-Marathon by T. J K. Patient ExpertHealth Maven Posted in: Blog Posts in General Medicine I was asked to post this advert for the NYC Half-Marathon to benefit the Freshair Children’s Charity. This seems like a worthwhile thing to do. The Fresh Air Fu ... Read on »
Inadequate testing? by T. J K. Patient ExpertHealth Maven Posted in: Blog Posts in General Medicine And this dear readers, is why we test our software…. Crash-alert system for Metro trains continues to fail By: KYTJA WEIR Examiner Staff Writer July 15, 20 ... Read on »
Super Busy by T. J K. Patient ExpertHealth Maven Posted in: Blog Posts in General Medicine My time has been largely booked with work. Travel has been quite extensive. In-house projects have been non-stop. As a result, there hasn’t been much time left for discr ... Read on »
21 CFR part 11 Update by T. J K. Patient ExpertHealth Maven Posted in: Blog Posts in General Medicine Folks, it looks like some of our US regulations and guidance documents have been flagged for update by FDA….including everyone’s favorite, 21 CFR part 11 (source Cerulea ... Read on »
Server Crash - what would the impact be? by T. J K. Patient ExpertHealth Maven Posted in: Blog Posts in General Medicine I was reading Eric Zeman’s post on the recent Nokia server crash in which *data was lost*. Server Crash Deletes 3 Weeks’ Worth of Nokia User Data posted Yesterd ... Read on »