All You Need to Know About Training Management System TMS.

All You Need to Know About Training Management System TMS

 

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.

Training Management System TMS Definition

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.

In either case, you can use cGMP training procedure templates or Training Management System Software Applications.

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.

When is Necessary a Training?

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:

  • Specification criteria for raw materials, internally/externally manufactured components, or internally/externally finished products
  • Packaging or labeling information, process, or materials.
  • The shelf life of raw material, components, or finished products
  • Process parameters
  • Tools or consumables (i.e. wipes, gloves, shoe covers, etc.)
  • Equipment or equipment settings
  • Qualified cleanrooms
  • Cleaning processes of the manufacturing environment or manufacturing equipment
  • Facilities or utilities
  • Locations for manufacturing, testing, sterilization, or warehousing
  • Environmental conditions of manufacturing, testing, or storage,
  • Control of monitoring processes for the manufacturing, testing, storage, or distribution environment
  • Suppliers or external manufacturers
  • Line re-configuration as it relates to operators changing from a seated to standing position, updates to the line and station layouts, or re-sequencing of process steps
  • Throughput time as it relates to changes to the material storage time between processes
  • Product handling techniques as it relates to material storage and conveyance
  • Working with multiple lots at different stations.
  • Layouts in areas of product handling like manufacturing and warehouse
  • Any change that can potentially impact form, fit, or function and the quality of the product.
  • Changes related to supplied items, raw material, components, or finished products in regards to:
    • manufacturing or assembly processes
    • control or monitoring processes
    • cleaning processes
    • product handling
    • inspection or release processes
    • configuration check inspections
    • sample size or sampling plans
    • method of testing (e.g. physical, analytical, microbiological)
    • packaging or labeling processes
    • sterilization process
    • storage, shipment, or distribution processes.

Why Initiate a Training Effort?

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.

How to Fill a Training Record Form?

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.

  • Training number:
  • Version
  • Reason and Description of the Training.
  • Related Topics, Documents, or Procedures.
  • What is included in the training?
  • Why is the training provided / justification?
  • How was the training performed?
  • Where was the training done?
  • When was the training done?
  • Training Duration
  • Training Type categorization
  • Impacted areas of the training and documents affected.
  • Training requirements
  • Training Execution Description
  • Exams Description, exam results evaluation, training implementation completion & training approval,
  • Training score, pass, or fail.
  • Trainee name and signature
  • Trainer name and signature

HOW TO AVOID MISTAKES IMPLEMENTING A TMS TRAINING MANAGEMENT SYSTEM.

  1. We suggest evaluating your current personnel positions and responsibilities to determine which quality management procedures, forms, work instructions, and training requirements are in each area, but, also consider the frequency of re-training.
  2. If you have a small number of employees to be trained, you can initiate a GMP training effort manually using hard paper.  In case you need to create or update your cGMP training procedure, you can use a template procedure to accelerate the process to implement a manual Training Management System.

Get a full template training procedure

Moreover, you can use free software applications to handle your Training Management System QMS Training necessary.

    • To get free training management system application software, click here.
Get a free training management system application software
Get a free training management system application software

TO RECEIVE NEWS AND USEFUL TOOLS IMPLEMENTING A TRAINING SYSTEM, SUBSCRIBE, AND FOLLOW US.


 brought to you by CIQA-thermal Mapping Distribution StudiesCIQA 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.

IF YOU HAVE ANY QUESTIONS ABOUT TRAINING MANAGEMENT, FEEL FREE CONTACT US (Hablamos Español)

REFERENCES:

  1. https://ciqa.net/training-management-procedure-template/
  2. https://ciqa.net/training-management-system-software-as-a-service-application/
  3. https://ciqa.net/product/training-management-system-application/
  4. https://ciqa.net/product/training-procedure-template/
  5. https://ciqa.net/how-to-fill-a-training-record-form/
  6. https://ciqa.net/why-to-initiate-a-gmp-training-effort/
  7. https://ciqa.net/when-is-necessary-a-gmp-training/
  8. https://ciqa.net/qms-training-necessary/
  9. https://ciqa.net/what-is-training-management-system/
  10. https://ciqa.net/training-management-system/
  11. https://ciqa.net/online-validation-training-in-english-and-spanish/
  12. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.25
  13. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.25
  14. https://www.fda.gov/industry
  15. https://ciqa.net/how-frequently-your-employees-must-be-trained/
Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!

Related Articles

Subscribe to get validation
news and free tips by email.

Need Additional Help?

Request for Quotation