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.

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.

HOW AND WHY INITIATE A GMP TRAINING EFFORT?

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

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 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.

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 initiate a GMP training effort 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 initiate a GMP training effort 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 initiate a GMP training effort.

    • 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 INITIATE A GMP TRAINING EFFORT, 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 INITIATE A GMP TRAINING EFFORT, 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