In this article, you will learn why to initiate a GMP training effort as per FDA requirements. In addition, you can learn how to get a Training Procedure Template and Training Management Software Application to handle your training activities more efficiently.
Some industries work under stricter training requirements due to the type of product and information they retain for privacy, warranty, or other highly regulated purposes.
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.
RECOMMENDATIONS TO AVOID MISTAKES WHEN YOU INITIATE A GMP TRAINING EFFORT.
Moreover, you can use free software applications to handle your Training Management System (eTMS) and facilitate the process to initiate a GMP training effort.
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CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. Rest assured of the safety or being in the right hands.
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