T. J. Kuhn | GxP Zone

Good Practice for the Pharmaceutical Industry from the Quality Assurance Perspective

Archive for April, 2008

SQA Conference

Posted by tjkuhn on April 18, 2008

This weekend, I leave for the week-long SQA conference in Memphis, TN. SQA is the Society of Quality Assurance (www.sqa.org), an organization of Quality Assurance Professionals in the Pharmaceutical (and related) industries. I didn’t make it last year, but I’ve been several times in the past and its usually a really great conference for training, sharing ideas, and “re-centering” away from the store, so to speak. We QA people spend a significant portion of our lives clarifying what it is we do…Its nice to spend some time with people  like Don Barzini (in The Godfather) who “don’t need to be told”.

I’m going to be taking a couple of pre-conference training courses, one on basic GLP (which I haven’t done directly in my career) and another on current (advanced) topics in GCP. I had hoped to present this year (probably on the use of Technology in Clinical Research), but with the job change and such, there really wasn’t time to prepare anything….and it was unclear whether I’d be able to go until about a month ago. Next year for sure.

I’ll try to post an ongoing log of my experiences at the conference and associated commentary. Perhaps it will be of interest to those are unfamiliar with the conference or those who just can’t make it this year (budgets being particularly tight at a number of Pharma companies at this point).

~TJK

Posted in cGMP, drugs, GCP, GLP, GMP, GxP, Pharma, Pharmaceuticals, QA, Quality Assurance, Technology | Tagged: , , | Leave a Comment »

eHR’s gone bad…

Posted by tjkuhn on April 17, 2008

I saw this on the Healthcareguy’s blog and thought it was worthwhile enough to post here too. In my experience, doctors are often not very tech-savvy (since they’ve spent an inordinate amount of time focusing on medicine, it stands to reason that they didn’t have as much time to monkey with computers and such). I could see this lack of tech-savvy make them “targets” of unscrupulous vendors/consultants in the emerging EHR (electronic health records) market.

Hi,

My name is Jim Edison and I work part time for a private, non-profit foundation called www.doctorsinperil.org. The foundation was started after a personal loss of the founder and its mission statement is to assist doctors in obtaining refunds from electronic medical records manufacturers for products that do not work as advertised. The EHR industry is new and many companies are taking advantage of doctor’s natural trust and naitivite. We do not take any money for our services.

We will investigate a complaint filed with us and if there is merit to the complaint, we will use the threat of public exposure to help the doctor or clinic obtain a refund. We also have a legal war chest and a law firm on retainer that may be used for class action lawsuits against companies that ignore our requests or who have a history of widespread abuse.

I am looking for the best way to tell doctors about our service, so please refer me to other popular sites that might allow us to post this announcement. Please feel free to visit our site and register if you have a complaint.

We have recently updated our site with two new sections titled, “Unscrupulous Practices By EMR Companies” and “ADVICE ON PROTECTING YOUR IT INVESTMENT”. They can be found here & here.

Thank you,

James Edison

~TJK

Posted in Data Integrity, Economics, Health Care, Healthcare, Technology | Tagged: , , , , | Leave a Comment »

Wow….

Posted by tjkuhn on April 16, 2008

In addition to a steady stream of inquiries from headhunters….ahem, recruiters, I also have several automated feeds from Monster, HotJobs, etc. I always know people who are looking to move in Pharma (a small and incestuous industry….we always see the same faces, just under a different sign). I have been aware of the compensation levels for positions with “Chief” in the job title, but it is another thing to see the dollar-figures in print on an actual solicitation….It definitely is a “wow” item:

Jobs Home > Job Search > NY > New York > Diedre Moire Corp. > Chief Medical Officer – Sr. Executive – PharmCo Clinical Research and Medical Affairs – NY
Chief Medical Officer – Sr. Executive – PharmCo Clinical Research and Medical Affairs – NY: Diedre Moire Corp.
View more jobs like this
Job ID 1583
Company Name Diedre Moire Corp.
Job Category Pharmaceutical/Biotech
Location New York, NY
Position Type Full-Time, Employee
Salary $600,000 to $900,000 per year
Experience 2-5 Years Experience
Desired Education Level Bachelor of Science
Date Posted April 1, 2008 (Reposted Apr 16)

Diedre Moire Corp.
View Diedre Moire Corp. profile and job listings
Apply Now: A Better Job Search Experience. Learn Why

Lead large Matrix Organization employing over one hundred medical doctors invloved in Medical Affairs and Clinical Research.

Requires 8+ years managerial experience with a pharmaceutical company and extensive Medical Affairs experience.

$600,000 base salary and comprehensive bonus, stock and perks.

Contact Dr. Gary Shinder, MD at:
609-584-9000 ext 273

Or apply online at:
http://dmc9.com/gls/app.asp

Or email to:
1000001583_10007224@candseek4.com

WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, sex, national origin, handicap, disability or marital status. We reasonably accommodate individuals with handicaps, disabilities and bona fide religious beliefs. Jobs Career Position Hiring. We will make every effort to consider applications for all available positions and shall use one or more of the contact methods and addresses indicated in resume or online application. Indicated location may be proximate or may be desirable point of embarkation for paid relocation to another venue. CONSIDERED EXPERIENCE INCLUDES: Pharmaceuticals

If you submit an application or resume, which contains your email address, we will use that email address to communicate with you about this and other positions. We use an email quality control service to maintain security and a remove and dead address filter. To cancel receiving email communications, simply send an email from your address with the word “remove” in the subject line to pleaseremove@candseek4.com If you have further concern regarding email received from us, call (609) 584-5499. We will be glad to have a real human being contact you upon request.


~TJK

Posted in Pharma, Pharmaceuticals, tjkuhn | Tagged: , | 1 Comment »

The Lot of the QA Road Warrior

Posted by tjkuhn on April 2, 2008

Over the last few years, I’ve been a lot of really neat places for work: Singapore, London, Argentina, Brazil, Mexico, Canada, and countless domestic (US) locales….and the travel destinations of my auditor colleagues would likely make up the difference for the rest of the world. This all sounds very exciting, very jet set, very sexy.

But the truth of the matter is that a little travel goes a long way. When we go, we sit in a conference room…..a conference room that looks like most other conference rooms….and read documents, interview people, make quick notes on legal pads as the auditees look on nervously. Usually, there’s no need for them to worry…we auditors are just making notes so that we can somehow distinguish their conference room (and the work presented there) from so many others we’ve sat in during the course of our careers.

There are many downsides to my chosen profession: justifying expenses to “Corporate Expense Processors” who may or may not know what we do (usually not), waiting to get our money back, sitting in airports, sitting on planes…sitting on planes on the tarmac….waiting. Actually, there’s a lot of waiting and a lot of time away from our families….this last part is hardest.

Don’t get me wrong, there are upsides as well. We do exercise a fair amount of autonomy and have the opportunity to really make a difference with our specific expertise and skill sets. That makes for a very satisfying career, but tonight, I’m in a mood to lament the woes of life on the road. I’m not one to drone on about the hardness of my lot, especially since I’m very pleased with my recent job change, but I think that it is important to mention the downsides to even the best of situations…..I’m an auditor; they pay me to look for the ugly underbelly. And its hard to turn that off.

Well, I’m on the West Coast, but I’m still on East Coast time….so I’ll be going to bed soon. I wish a good night to all.

Best,

TJK

Posted in Audit, QA, Quality Assurance, Travel | 3 Comments »

 
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