Stepping up to the partnership plate
07/01/2002
You've got a great arm and major league aspirations. And by some miraculous blessing, two of the greatest pitchers in baseball, Pedro Martinez of the
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Boston Red Sox, and Randy Johnson of the Arizona Diamondbacks, offer to share their secrets-insights that perhaps could pave your way to The Show.
Some may consider this scenario unrealistic, but there are plenty of heavy hitters in the contamination control industry who remain poised to impart wisdom that will most certainly save companies millions and may even propel careers to new heights.
Elaine Messa is one of those heavy hitters.
The former inspector for the U.S. Food and Drug Administration (FDA), who now works as a consultant, recently gave a presentation at a heavily attended medical device show in New York City. One might think her presentation "FDA Inspections Made Easy" would be the equivalent of posting a "Free Beer" sign at a Red Sox game, but the thirst for knowledge has in someway been quenched by apathy, for only a dozen people from the thousands who attended the tradeshow showed up.
The attendees who did show up, however, expressed a great deal of disdain for their federal counterparts, regarding inspections and inspectors as sticks in the mud who just get in the way of whatever the drug maker or medical device manufacturer deems as progress.
"How many people feel comfortable when the FDA arrives at the door?" Messa asked her audience.
Only two people raised their hands. The rest, some with their arms crossed defensively, smirked.
Medical device manufacturers and drug makers alike often refuse to discuss their experiences with FDA inspectors with CleanRooms, so the magazine is left with using a dozen or so people as a barometer of the relationship. The attendees surely provided a glimpse of a delicate balance between two groups existing on the cusp of the adverse. One attendee even said the most important part of an FDA inspection is getting the compliance officers out of the plant as quickly as possible.
That's why it just does not make any sense that there was not more of a turn out for a presentation given by a former FDA inspector, who has more than 30 years experience in the field.
Messa provided the whom, the what, the where, the why and the how, and those who heard what she had to say are that much more on the ball. Those know-it-alls who didn't might just keep striking out.
While the FDA does a fine job at providing direction and communicating its mission, experts like Messa bridge the gap, evoking a philosophy that aims at changing a relationship that resembles the one between Yankees and Red Sox fans into a strengthening partnership.
Mark A. DeSorbo
Associate Editor