A new position

I’ve been quiet over the past couple of weeks because I’ve been tremendously busy. This is my last full week here at sanofi-aventis. I have accepted a new position with another pharmaceutical company and am trying to closeout all open items. 

I am both excited about the new position (which is a QA Validation position supporting Clinical Research) and sad to be leaving my current position. I’ve had the privilege to work with a great team of people here whom I will miss greatly. Still, ours is a small industry. This likely won’t be “goodbye”, but rather “goodbye for now”.

 I will get back to more frequent posting once I have cleaned my proverbial “plate”.

~TJK

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Roles for QA

I was scanning through my email subscriptions today and noted an interesting item in my FDA News Drug Daily Bulletin (from the company “FDA News”) advertising one of their publications. Now, most of the time these “industry best practice” white papers are information that is common-sensical or freely available from another source (e.g., compilations of FDA Warning Letters that are available on the www.fda.gov website) so I typically ignore them. However, the tone and posturing of this one caught my eye:

 

Lower Your Site Risk Potential (SRP) Score
Lower Your Site Risk Potential (SRP) Score zeroes in on what this risk-ranking model is and how FDA is using it to classify manufacturing plants and prioritize enforcement. This new management report also goes a vital extra step, showing you how to implement practical strategies that can reduce your score, limit inspections and unlock a host of valuable new business benefits.
To order, go to http://www.fdanews.com/store/product/detail?productId=23141.

 

To me, that is marketing to the worst of us. It doesn’t offer help to actually improve one’s processes, systems, or products so as to have more successful inspections. It implies that by doing certain things, a manufacturer can place themselves “below FDA’s radar” and thereby reduce the number of inspections to which one is subject. That is not to say that the advertisement is selling a lousy or unethical document. I wouldn’t know since I haven’t read it.

The ad did get me thinking about the various roles I play as a QA Auditor though. I was born an optimist, but through my work in QA, I’ve become somewhat of a reluctant realist. There are always those who will seek out “the quick and easy path” rather than the high road. That being said, my role varies depending upon with what I’m dealing:

 

1) In my opinion, most people I meet and with whom I’ve worked are genuinely interested in doing a good job, the right thing, etc.; and for that I am thankful. And as a QA professional, my primary job is to help them do just that. By serving as a fresh pair of eyes, as an uninvolved outsider, I can help those who may be by necessity focused on the trees, see the forest. This is the role I like best, that of an internal consultant.

 

2) In other instances, there are those who are very ready to make what a former mentor of mine liked to call “overly pragmatic decisions”. For situations like this, my role tends to be more akin to that of a traffic cop. Almost everybody slows down when they see a parked patrol car. My presence lets people know that “someone is looking”.

 

3) In the worst cases, I’m there to catch the most aggregious offenders, those who totally disregard ethical or moral considerations; or who are just so sloppy in their practice that they pose a major risk to their subjects, the public, or the research itself. I play the role of the enforcer in these cases. I like this role the least. However, I try to remember that it is because of this minority situation that there will always be a role for Quality Assurance.

 

~TJK

Healthcare IT Guy supports Institution Browser Lockdown

Not long ago, the Healthcare IT Guy, Shahid N. Shah, proposes that healthcare institutions ought to lock down their browsers to prevent all unofficial use or as he calls it “misuse”:

Healthcare IT GuyMore and more healthcare applications are being re-platformed to run as web applications. While it’s good for ease of deployment, this means that staff that had no business using web browsers before now have valid work reasons to run browsers. This may lead to “unofficial” use of office browsers for non-healthcare use such as shopping, reading the news, playing on FaceBook, or other types of misuse.

While some misuse may be acceptable because all it does is waste time, other types of misuse like downloading files, playing music online, etc will cause viruses to enter the network or may take up valuable network bandwidth.

I recommend locking down your browsers so that staff can only use it appropriately. Check out these tips and directions to help prevent most common misuse of Internet Explorer. While these are not foolproof, they will take care of basic restrictions.

While there are indeed inappropriate uses of an institution/employer’s technology, applying a unilateral block on all personal use generally results in employees who are disinterested in using the technological solutions implemented by employers. The main reasons for this hinge on the following:
1) Unfamiliarity/Discomfort with technology (People take the time to *really* learn technology by using it to do something in which they have a *personal* interest)

2) Feelings by the users that management does not trust the users or care about their personal needs that full lock downs tend to cause.

It is easy to lock down. It is easy to leave things completely open. It takes some thought to keep things secure between these two extremes.

~TJK

New Draft EMEA Paper on Electronic Source Data

Source data, the original entry for data in research or manufacturing, is expected to contain certain elements of Quality in the Pharma industry. These elements are often expressed with the acronym ALCOA (i.e., Attributable, Legible, Contemporaneous, Original, and Accurate).

When the data is in electronic format, the logistics of this change somewhat, and more guidance/clarification is typically needed. The Food and Drug Administration, FDA, has ruled on electronic data as source for clinical trials in the past.

Now the EMEA, the EU’s regulatory authority has published a draft paper outlining their expectations as to the use of electronic source in Clinical Trials. They have requested comments from industry stakeholders, experts, etc. by this April.

I have worked extensively in evaluating electronic data issues, especially in how they relate to clinical research, so I am very interested to see how  how EMEA’s position varies from FDA’s. I will be reviewing this paper thoroughly and time permitting, I may include a summary here.
~TJK

What’s this whole QA? – Part 2

Happy New Year,

Life and work have been very busy since my last post in October. As a result, blogging has taken a decidedly backseat. And so it goes.

At this point, I’d like to pick it back up though and continue where we left off. Quality Assurance in the Pharmaceutical (and related) Industries. Now, if one looks up the subject of Quality Assurance on Wikipedia (an online resource that I highly recommend, by the way), we get the industry independent, generic, vanilla description of what QA is:

Quality assurance, or QA for short, is the activity of providing evidence needed to establish quality in work, and that activities that require good quality are being performed effectively. All those planned or systematic actions necessary to provide enough confidence that a product or service will satisfy the given requirements for quality….

Now, that’s not a bad start. It does cover some of the key concepts with regard to manufacturing, particularly in industries other than Pharma. However, it does little to address the particular nuances of what quality is in terms of Pharma Manufacturing and Pharma Research.

Previously, I talked a bit about the whole point of QA being related to Safety and Data Integrity. The Pharmaceutical Industry is among the most regulated in the world (particularly in the US). In fact, it is often stated that Pharma is more regulated than Nuclear Engergy. Now, I don’t know whether that is definitively true, but I think just being in that ballpark gives us some context for my next points:

1) People expect more from their medicines. *That* is why they are so regulated.
2) QA has a unique role in the Pharmaceutical and related industries. This is a core reason for this Blog to further explore what this means.

I’m going to continue writing on this topic, but in bite-sized posts rather than longer, more polished essays. We may get to the essays eventually, but I think it is more important to get some of this stuff down.

~TJK