What is a Training Management System TMS as per cGMP?

What is Training according cGMP

 

In this article, you will learn what is a Training Management System according to FDA requirements.  Also, you can learn how to get a Training Procedure Template and Training Management Software Application to handle your training activities fast and easily.

The FDA requires medical device and drug manufacturers to maintain trained employees in a predetermined frequency.

Its requirement is defined in 21 CFR 211.25 for pharmaceuticals and 21 CFR 820.25 for Medical Devices.

It states that “companies must ensure that their personnel has the education, training, and experience, to perform their assigned duties.”

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.

The Training Management System is the program designated to handle your entire tuition operations specifically related to cGMP activities.

The TMS is used by the pharmaceutical and medical devices industries to manage regulatory requirements and training records.

Moreover, it organizes educational curriculums, schedules, class delivery, grading, records, and history.

THE TOP 6 TYPES OF TRAINING ARE:

  1. e-learning,
  2. online,
  3. computer-based,
  4. self-training
  5. classroom, or
  6. 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 tuition programs.

Some companies use dedicated software for this purpose, other companies handle their training management system more manually.

The TMS includes the control and handling of all 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.

The first step to implement a Training Management System is reviewing your Quality Management Systems procedures.  In case you need help to create or improve your Quality Management procedures, consider using one of our template documents.  To see the complete list of the most popular Quality Management procedures templates, click here.

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

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 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
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!

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