Legal Counsel: Complying with PDMA
Ensuring FDA compliance starts with establishing standard operating procedures. Whether a company chooses to go with an electronic or paper-based solution for sample accountability, it must have procedures in place to prevent disaster.
“It’s not easy, especially for the almost 1,800 small and midsize pharmaceutical companies that represent the majority of firms in the industry,” says Don Schenker, president and CEO of Synergistix Data Solutions. “Many of these firms have reps who are not company employees, making sample accountability even more difficult to monitor.”
With penalties ranging from $250,000 to $1 million, the key is to establish procedures and put them in place as soon as possible to help ensure PDMA compliance. According to Mr. Schenker, the important thing to realize is that sample accountability is not something that can be “taken care of” once or twice a year. It is an ongoing process in which pharmaceutical firms must produce accurate information on demand.
Expert on this Topic
Don Schenker, President and CEO, Synergistix Data Solutions