Expert: Firms Should Ensure Adequacy of Training Programs

As the FDA has moved to a systems-based approach for inspections, pharmaceutical manufacturers should ensure that their GMP training programs are effective, Kristina Spitler, a training manager with clinical trial materials packager and distributor Almac Clinical Services, said.

“We’ve seen a record number of warning letters from the FDA on training observations,” Spitler said during an FDAnews audioconference on effective GMP training.

“We’re seeing a lot of training observations now because the FDA has moved to systems-based inspections where they’re focusing on quality systems every time,” she said. “Training, I believe, is an integral function of the quality system and it can affect your quality compliance throughout the organization.”

Reasons for ineffective training programs include high-intensity sessions and having employees sign off on lengthy procedures without instruction, as well as faulty evaluation of training program effectiveness.

“If you’re requiring too much, you’re probably diluting the really important [material],” Spitler said. She added, “Here’s an actual excerpt of a 483 ... ‘Employee had a training record showing training on 67 written procedures in one day.’ Now, how effective do you think that was?”

Spitler said that she tries to limit training for standard operating procedures to five per day or fewer, depending on the complexity of the procedure. She also tries to limit training sessions to two hours with a maximum of 25 employees per class.