In this article, you will learn about the Training Management System TMS as per FDA requirements. In addition, you can find out how to get a Training Procedure Template and Training Management Software Application to handle your training activities more efficiently.
A Training Management System is the program designated to handle your entire training operation. It is used by regulated industries for compliance training and defined in 21 CFR 211.25 for pharmaceuticals and 21 CFR 820.25 for Medical Devices.
The FDA allows you to establish your training program manually or electronically.
It will manage the training requirements, sections, and training records. Moreover, it organizes training curriculums, schedules, training delivery, grading, records, and history. Types of training delivered include e-learning, online, computer-based, classroom, or simulator learning environments.
A training management system is a program either manual or electronic intended for the administration, documentation, tracking, and reporting of instructor-led-training programs. Some companies use dedicated software for this purpose, other companies handle their training management system more manually.
The training management process includes managing and maintaining training records of the organization’s employees. A TMS manages instructor-led-training administration, session registration, course administration, tracking, effective monitoring, and reporting. In some cases, they are capable to manage financial aspects, including budget forecasting and cost-tracking.
TMSs can be complemented by a learning management system for e-learning management and course delivery.
What Kinds of Training Must Your Organization Accomplish?
Even though OSHA training, hazmat training, and other company-specific training must be covered by your organization, we aim more specifically to the GMP training necessary and required by the FDA and the QMS Quality Management System. Sometimes initial training is followed by a requirement of additional recurrent training within six months, or perhaps one, two, or three years later.
What is the Frequency of Your Employees’ Training?
Many federal regulations and company policies require to comply with specific training schedules, control of approving trainees’ courses, view completion dates, test scores, and detailed information such as duration of actual training time or frequency.
In some cases, each company establishes its own frequency of employee training based on a risk assessment. Based on this information, a recurrent training date or frequency can be generated, and if required, certificates of completion can be sent and stored in a trainee’s history in the Training Management System TMS.
Training is needed whenever a change is introduced to the established GMP procedures, batch record instructions, specifications, equipment settings, validated process, material, product, etc.
More specifically, training must be done and documented in the Training Management System TMS if you add, modify, or impact any of the following areas:
Government regulations require that companies working in pharmaceutical industries bring training to their employees. Its requirement is defined in 21 CFR 211.25 for pharmaceuticals and 21 CFR 820.25 for Medical Devices.
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 and the QSR mandate to establish a training program also called a Training Management System TMS.
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.
The training record may include, but, is not limited to complete the following sections and information related to the training provided to the employee, (as applicable) in the Training Management System TMS.
HOW TO AVOID MISTAKES IMPLEMENTING A TMS TRAINING MANAGEMENT SYSTEM.
Moreover, you can use free software applications to handle your Training Management System QMS Training necessary.
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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.