tjkuhn.jpgWelcome to GxP Zone. I’ve had this domain (www.tjkuhn.com) for many years now, but it has mostly served as just a placeholder for “something” in the future. Not long ago, I became excited about blogging after listening to a book-on-tape of Robert Scoble and Shel Israel’s book on the subject, Naked Conversations. Since then, I’ve been reading blogs and planning my own contributions, but have been struggling as to how to start. I’ve come to the conclusion that it really doesn’t matter how I start, just that I do. So here I go, midstream and mid-thought.

I’m a Quality Assurance professional working in the Pharmaceutical sector. In that role, I see a lot of things. The point of this blog is to share some of that. Additionally, I’m hoping that through the related ongoing dialog on the blogosphere that I will be able to learn new things, broaden my perspective, and refine my own positions.

We will see how my blog develops, but for now, I’m planning on covering a wide range of compliance, bioethics, and technology issues. My initial target audience will be professionals working in (or in conjunction with) the Pharma industry. I’ll be looking at things from the GxP perspective. That being said, I can easily envision posting information that may be interesting or useful to consumers who are interested in the health care system; its past, present, & future; and why it works like it does. We will have to see.

Now it is time for disclaimers. I have a favorite that I’ve seen around the web (though I can’t seem to find it now):

The views expressed within are opinions. They are not necessarily those of my employer, not necessarily mine, and probably not necessary.

Let me explain:

1) Nothing on this site, neither explicit nor implied, should be construed as an official or unofficial position of my employers (past, present, or future).

2) Some of the items I post will be borrowed ideas. If I know where something comes from, I will attribute it. Please let me know if you know of the source of an idea that I haven’t and I’ll gladly add appropriate references.

3) My posts will include items with various degrees of polish. Some of them I’ve been thinking about and developing for decade(s)….and some of them I thought of ten minutes ago. My thoughts will likely change over time. Please challenge me if you feel my position on any topic is misguided. That is part of the point of this blog and I will be very thankful for the input.

4) I serve as an advisor to my clients on compliance issues. If I work with you (and doubly so, if I do not), opinions that I express here are just that….opinions. Do not construe anything I write here as definitive, official, well-researched, or prescriptive. If you want something official, please contact me directly.

With that, let’s get on with the dialog.


~T. J. Kuhn

I can be reached at tjkuhn _attttt_ tjkuhn _ddddoooottttt_ com



  1. Thanks very much, John. I’m moving very slowly and sure-footedly at this point. Partly because of the nature of the Pharma field, but also because I’m really swamped right now at work. I’m hoping to start with a major post/week and see where it goes from there. Thanks for dropping by.




  2. Thanks Donna,

    I’m hoping to have more stuff up here more frequently in 2008. Yeah, my resolution says something about averaging 2-4 posts/month.




  3. Hello Timothy,

    As someone who is in the ealry stages of learning about the industry, I enjoyed reading your posts and information.

    Best regards,
    Steve Horner
    Devon Consulting



  4. Tim,

    Would you ever consider relocating to Northern California? A client of mine is looking for a Sr. Clinical Quality Specialist like yourself. They are a growing pharmaceutical company in the San Francisco Bay area with about 500 employees.


    Mark Grundler
    Account Manager
    Clinical Resource Group
    Ph: (760) 597-1700 x104



  5. Hi Mark,

    You’re about the 10th recruiter to contact me about what I suspect is the same job (or group of jobs). Thanks very much, but I’m not looking to move at this time. Good luck filling the position.




  6. I was fortunate to come across your blog today. I’ve been working in a small CRO for the past 3 years now, two of which were spent in QA. I am a clinical trial newbie and overcame a huge learning curve. With that said, I have a long way to go and much to learn still. Barnett GCP auditor course is an invaluable education. I found your posts clear and to the point. Thank you for doing this,



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