Actions Speak Louder
I don't know which FDA group you deal with, but based upon personal experience quite recently, the FDA is doing nothing of the sort stated in Keith Larson's editorial, "Six Sigma, Here We Come" [Pharmaceutical Manufacturing "Winter/03, p.5].
Quite the opposite, they are working diligently to emphasize the current validation requirements and require even more stringent ones. Perhaps you could share some examples on how the FDA wants "...to help drug makers better negotiate its sometimes over-onerous validation procedures, and to pursue process improvements that make business sense."
The editor responds: My statement that FDA is "giving clear indications" of its intent to do so drew primarily on FDA's latest published GMP guidances, most notably in the areas of process analytical technology and comparability protocols. In the latest PAT guidance, for example, the FDA says that its "new strategy is intended to alleviate the fear among manufacturers that introducing new manufacturing technologies will result in regulatory impasse." The recent guidance on comparability protocols, too, explicitly states that FDA's intent is to "identify and implement opportunities for managing manufacturing changes without the need for prior FDA review or approval."
These are of course, only statements of intent "how and whether they are translated into reality remains to be seen, and of course we'll share examples when we find them!
Quality Control Needed
In Keith Larson's editorial, "Six Sigma, Here We Come," the quote on ceasing dependence on inspection was incorrectly attributed to Dr. W. Edwards Deming.
The quote is actually from an article by Brian L. Joiner and Marie A. Goudard entitled "Variation, Management, and W. Edwards Deming," [Quality Progress--12/90, p.35], where they provided their interpretation of Deming's "14 points for Management." The particular quote referred to Deming's point #3: "Cease dependence on inspection to achieve quality. Eliminate the need for inspection on a mass basis by building quality into the product in the first place."
Rick E. Cooley, Team Leader
Process Analytical Measurement Technology
Eli Lilly and Company
I am a recent B.S. biology graduate and am now working as a laboratory technician at a food grade pharmaceutical company. The company is worldwide but my pay isn't. I read through Agnes Shanley's editorial "The Rise of the Paraprofessional" [Pharmaceutical Manufacturing "Winter/03, p.64] and it appears that there are many jobs in this type of field. Can you direct me toward any opportunities in New York or New England?
The editor responds: There are quite a few opportunities, particularly if you're willing to move into biotech/bioprocessing. You should definitely hook up with local chapters of Bio-Link (http://www.bio-link.org/centers.htm). Check out the "Career Scenarios" section of their website--you'll see some examples of people who went for more training after getting a B.S. and found more, and more attractive, job opportunities.
Regarding current openings, many of these jobs may not be published at all, so if you're not afraid of cold-calling companies in the locations you're most interested in, and schmoozing with plant managers and hiring executives (or, at least, gaining access to them by establishing contact with their assistants), you may end up with some very strong leads.
You might consider taking a few hands-on technician or manufacturing courses that give you actual experience operating new instrumentation and software. For example, junior college courses specializing in quality or some critical aspect of manufacturing that interests you. Even though you already have a B.S., you'd also gain access to the school's placement office and its services as well as access to general job listings. And, if you decided to pursue a certificate on a part-time basis, you'd have documented proof of manufacturing experience, which seems to make a difference for companies who may fear they'll have to provide a lot of training. You can get a certificate in one year and several courses are available on-line. Best of luck!
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Write to us at Pharmaceutical Manufacturing, 555 W. Pierce Road, Suite 301, Itasca, IL 60143. Send faxes to Keith Larson, Editorial Director, at 630/467-1124. Send emails email@example.com. Submissions may be edited for space or clarity.