Traditional methods for training new employees may be failing devicemakers, as most Form 483 observations can be traced back to training deficiencies, several experts say.
“I’m still seeing a lot of firms that use ‘read and sign’ training, which really isn’t adequate,” says Steve Niedelman, lead quality systems and compliance consultant with King and Spalding. This type of training doesn’t demonstrate the trainee’s ability to use the knowledge, and it’s not just smaller companies that are making this mistake, he notes.
The good news is that there is now “a transition to hands-on instructor-led or computer-based training that challenges the trainee to demonstrate some level of proficiency,” Niedelman says. This is a result of increased FDA oversight of training materials.
Training is Improving
Niedelman, a former FDA deputy associate commissioner for regulatory operations, advocates switching from a “training-based environment” to a “learning-based environment.” This involves demonstrating, either through proficiency testing or hands-on training, that the employee has learned how to do something and can apply it correctly, he explains.
Dave Gallup, principal with Training and Communications Group, agrees that devicemakers are increasingly providing “sound training,” with measurable objectives and stated goals. This type of training requires a formal program with clear, stated objectives of what is to be accomplished by the end of the training. To complete the training, there should be a test, he says.
Still, Gallup sees too many companies train employees by having one follow another, and then asking the established employee to sign off on the new hire without measurable evidence. “That’s where so many companies fall down,” he says. “They do not have a formalized training program to teach people the skills and knowledge they need to do their specific job.”
Companies that rely on this type of training can usually get by until there’s an incident. “That’s when the agency starts to really look at people’s training,” Gallup says.
Devicemakers whose training programs have undergone FDA scrutiny — and particularly enforcement actions — run the risk of overbuilding their training programs, Niedelman warns.
For example, companies may train employees in areas that are not applicable to their daily work, which is frustrating and confusing for them. “There should be different levels of proficiency associated with what you’re going to be doing,” Niedelman says.
SOP Review Urged
Another common problem Niedelman sees is companies training employees only once or offering a single training on a particular topic. “There needs to be some level of continuous training,” he advises.
As an additional tip for devicemakers, Gallup recommends reviewing and rewriting standard operating procedures to make them simpler and more user-friendly. “So many companies have SOPs that are out of date, unclear, inaccurate or aren’t easy to follow,” he says, noting that these are the documents used in training.
This topic will be discussed in depth at FDAnews’ 9th Annual FDA Inspections Summit, Oct. 22 to 24 at the Doubletree Bethesda Hotel in Bethesda, Md. www.FDAInspectionsSummit.com.
In addition to Niedelman and Gallup, the panel will feature Lori Lawless, a medical device specialist in the FDA’s Office of Regulatory Affairs; Connie Hoy, vice president of global regulatory affairs for Palomar Medical Technologies; and Len Valenti, senior consultant with EAS Consulting Group and a former FDA policy analyst. The session is scheduled for Thursday, Oct. 23, from 2 pm to 3:30 pm. — April Hollis
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