How to Fill a Training Record Form as per cGMP Requirements?

How to Fill a Training Record Form as per cGMP Requirements

 

In this article, you will learn how to fill a training record form to comply with the FDA requirements described in the 21 CFR Part 211.25 and 820.25 Personnel.  Also, you can discover how to get a Training Procedure Template and Training Management Software Application to handle your training activities fast and easily.

The FDA allows you to fill the training records manually or electronically.

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

In any case, here we are providing a guide with some recommended information that can be documented as part of your training record, but, you can modify and adjust it to your needs related to the specific training provided to the personnel as part of your Training Management System TMS.

THE FOLLOWING 10 FIELDS OF INFORMATION CAN BE DOCUMENTED IN A CGMP TRAINING RECORD:

  1. Training number.
  2. Reason and Description of the Training.
  3. What is included in the training?
  4. Why is the training provided / justification?
  5. How was the training performed?
  6. Where was the training done?
  7. When was the training is done and what duration?
  8. Exams score: pass or fail.
  9. Trainee name and signature.
  10. Trainer name and signature.

RECOMMENDATIONS TO AVOID MISTAKES WHEN YOU FILL A TRAINING RECORD.

  1. We suggest evaluating your current personnel positions to determine which procedures, forms work instructions, and training requirements are needed to operate the equipment and materials in each area, but, also consider the frequency of re-training.
  2. If you have a small number of employees to be trained on your site, you can fill your training records manually using hard paper.  In case you may need to create or update your cGMP training procedure, you can use a template procedure to accelerate the process to fill a training record and implement a manual Training Management System according to the cGMP.

Get a full template training procedure

Moreover, you can use free software applications to handle your Training Management System (eTMS) and facilitate the process to fill a training record.

    • 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 ON HOW TO FILL A TRAINING RECORD FORM AS PER CGMP REQUIREMENTS, 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 HOW TO FILL A TRAINING RECORD FORM, 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!

Related Articles

Subscribe to get validation
news and free tips by email.

Need Additional Help?

Request for Quotation