Why to Initiate a GMP Training Effort as per FDA Requirements?

HOW INITIATE A GMP TRAINING EFFORT?

In either case, you start manually using a cGMP training procedure template or electronically using a  Training Management Software Application.

FAILING TO COMPLY WITH THE TRAINING REQUIREMENTS, CAN CAUSE FINES, LOSS OF BUSINESS, OR DAMAGE TO A BUSINESS’S REPUTATION.

Moreover, the GMP Good Manufacturing Practices and the QSR Quality System Regulations mandate to establish a training program also called a Training Management System TMS, either manual or electronic.

In addition, the training management system serves as a logbook and tracking system of all training in the chronological order that was done. It helps to bring the evidence that training has been done to each employee by date and topic (or process) during its life cycle.

CONSEQUENCES TO NOT INITIATE OR NOT PERFORM AN ADEQUATE TRAINING ON TIME?

Failure to adhere to proper Training Management System TMS and training delivery is considered a violation of US Federal regulations on good manufacturing practices.

As a consequence, medicine or medical device can be termed as adulterated or substandard if the company has failed to bring training, and failed to design and implement an effective training control program or management system either manual or electronic.

In some cases, it may result in an FDA warning observation, product hold, product recall, etc.