|Workforce Training Bonus: Talks with Industry Experts
In a warning letter sent earlier this year to a maker of over-the-counter skin-care products, FDA wrote: “You failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or combination thereof, to enable that person to perform their assigned functions.”
The letter continues: “For example, your ‘QC/ R&D Chemist’ has not been trained to perform specific tasks such as microbial limits testing . . . Your response is inadequate because you have not established completion dates and training programs for current good manufacturing practices and SOPs.”
The admonition is not unlike many found in warning letters from the past year. Better get used to it, experts say. Employee training—and the documentation of it—is on FDA’s radar.
FDA “is trying to get to the root cause of a lot of the problems they’re finding” during investigations, says consultant Michael Gregor, president of Compliance Gurus, Inc. Whether these problems lie in Quality Control or elsewhere, the Agency wants to know whether manufacturers have the right people doing the right jobs, and that they can prove it. Meanwhile, Gregor says, FDA is intensifying scrutiny of issues related to 21 CFR Part 11—including training records and electronic signature authorizations—and sending dedicated Part 11 investigators on inspection visits.
Bill Ciambrone, senior VP for technical operations at Shire Human Genetic Therapies, has also noticed the Agency’s change. ”They recognize that there are so many deviations that are related to training,” he says. “I would venture to say that in many instances, manufacturing failure is oftentimes due to a failure to properly train personnel. It’s one thing that comes up when we look at deviations and investigations—have our people been appropriately trained so they can perform their functions adequately?”
Another issue of consequence is the effectiveness of training. In its August 30, 2010, letter to Bristol-Myers Squibb regarding its Manati, Puerto Rico facility, the Agency wrote: “Please provide a plan that evaluates your training program, specifically the program's effectiveness and your assurances of personnel compliance to aseptic processes prior to certification to work in an aseptic area.”
The upshot: Manufacturers, like it or not, need to reevaluate the training records of their employees, how they manage and monitor training, and whether or not it produces its intended consequences.
Not a Good Time
FDA’s renewed emphasis comes at a time when manufacturers are struggling to manage their workforces and ensure that the right people are doing the right jobs. With mergers and acquisitions rampant, and manufacturers cutting costs and “leaning” their operations (i.e., fewer people doing the same amount of work), maintaining a consistently competent workforce is a challenge.
Nowhere is this better exemplified than at J&J’s McNeil division, whose quality control and personnel problems have been well documented. Many of them derive from the fact that products in question were brought over in the purchase of Pfizer’s consumer health care division, and their production transferred, on the cheap, to McNeil’s now notorious Fort Washington, Pennsylvania facility.
“There were no wholesale layoffs in quality control,” wrote Mina Kimes in a recent Fortune article. “Instead experienced staffers were repeatedly laid off and replaced with newbies who mostly lacked technical pharmaceutical experience. By 2008 the analytical laboratory, formerly staffed almost entirely by full-time scientists, was half-full of contract workers, according to a former manager there.”
“Those product handoffs are expensive and difficult,” says regulatory consultant John English. “And when you move, you lose the collective memory or oral history” that production personnel have of a product.
Add to that the fact that a lot of the industry’s expertise is retiring (or being forced to do so), and you’re left with fewer plant-floor operators and other professionals who really know what they’re doing. Meanwhile, training and travel budgets have been slashed. No longer can manufacturers afford to take personnel off the lines for a week or two of seminars and certification programs.
Most warning letters of late reference poor or inadequate training, English has noticed. “The tea leaves would say it’s an issue,” he adds. “It’s always been an issue, but backwards. If there were problems at a manufacturer, the company would say that they’ll train their workers [to address the problems]. But I always ask, how good were their training systems in the first place?” And it appears FDA has this interest, too, he says.