Why to Initiate a GMP Training Effort as per FDA Requirements?

Why to Initiate a GMP Training Effort

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.

WHY INITIATE A GMP TRAINING EFFORT?

ANSWER:

Government regulations require that companies working in pharmaceutical industries bring training to their employees.  Refer to the 21 CFR part 211.25 and  21 CFR part 820.25

FDA regulated industries work under stricter training requirements due to the type of product and information they retain for privacy, warranty, or other highly regulated purposes.

HOW INITIATE A GMP TRAINING EFFORT?

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

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.

TRAINING MANAGEMENT SOFTWARE APPLICATION

Moreover, you can get a free Training Management Software Application to handle all your training records, curriculum, sections,  and events from anywhere at any time.

This cloud application allows you to bring follow-up and notifications necessary to guarantee that all your employees are properly trained, including: 

   1. Group Live Training Sections from Curriculum.

   2. Individual Self Training. 

 

Subscribe to receive updated information and learn more about training management.


 

RECOMMENDATIONS TO AVOID MISTAKES WHEN YOU INITIATE A GMP TRAINING EFFORT.

  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.

TRAINING MANAGEMENT PROCEDURE TEMPLATE

WHAT IS A TRAINING MANAGEMENT PROCEDURE TEMPLATE?

The cGMP training management procedure template is a downloadable document ready to use and customize to handle your company’s needs of employees training as per 21 CFR Part 211.25 and Part 820.25 personnel.  You can get a fully editable in MS Word format or a more affordable price in .pdf format.

ORDER ONLINE TRAINING MANAGEMENT PROCEDURES & TEMPLATES

Now you can download a training management document and templates fully editable in MS Word or get a hard-copy and Amazon Kindle format, ready to fill, and use according to your cGMP needs, check the following documents and see more information at the CIQA Shop. 

MORE VIDEOS ABOUT TRAINING MANAGEMENT

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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.

IF YOU HAVE ANY QUESTIONS ABOUT TRAINING MANAGEMENT, FEEL FREE TO CONTACT US EITHER BY EMAIL OR PHONE: 787-487-9235.  (Hablamos Español)

REFERENCES

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https://ciqa.net/wp-content/uploads/2021/07/CIQA-Training-Procedure-Template-Free-Sample-Version.pdf

Ecommerce

https://ciqa.net/validation-protocol-templates/

https://ciqa.net/thermal-mapping-protocol-template/

https://ciqa.net/product/validation-management-software-application/

https://ciqa.net/product/temperature-data-loggers-rental-puerto-rico/

https://ciqa.net/product/thermal-mapping-protocol-template/

Blogs

https://ciqa.net/training-management-procedure-template/

https://ciqa.net/training-management-system-software-as-a-service-application/

https://ciqa.net/product/training-management-system-application/

https://ciqa.net/product/training-procedure-template/

https://ciqa.net/how-to-fill-a-training-record-form/

https://ciqa.net/why-to-initiate-a-gmp-training-effort/

https://ciqa.net/when-is-necessary-a-gmp-training/

https://ciqa.net/qms-training-necessary/

https://ciqa.net/what-is-training-management-system/

https://ciqa.net/training-management-system/

https://ciqa.net/online-validation-training-in-english-and-spanish/

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.25

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.25

https://www.fda.gov/industry

Amazon

https://www.amazon.com/dp/B09FNGP1ZF

https://www.amazon.com/dp/B09FNJY2QZ

https://www.amazon.com/dp/B09FKR1BPL

https://www.amazon.com/dp/B09FC3S361

https://www.amazon.com/dp/B09FHG77R9

https://www.amazon.com/dp/B09FC9ZB6D

https://www.amazon.com/dp/B09H4TZR7F

 

 

Youtube

https://youtu.be/t60zspzgenw

https://youtu.be/Y40247ctXw0

https://youtu.be/rxnHnCpVXaM

https://youtu.be/K_ahAJ8NPoA

https://youtu.be/0UswONQz6sQ

https://youtu.be/QDCY8SjXSJk

https://youtu.be/jIYaQCrFVBw

https://youtu.be/9bPBZIaKYco

 

Training Management

https://youtu.be/Z-YU7x553KI

https://ciqa.net/quality-management-software-application/

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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