Top 10 Reasons When is Necessary a GMP Training as per FDA?

When is Necessary a GMP Training as per FDA Requirements

In this article, you will learn the top 10 cases when is necessary a GMP training 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.

IS TRAINING NECESSARY?

Training is needed whenever you create or modify your standard operating procedures, batch record instructions, specifications, equipment settings, validated process, material, product, etc.

WHEN IS NECESSARY A GMP TRAINING?

More specifically, training must be done and documented manually or electronically if you add, modify, or impact any of the following 10 areas:

  1. Specification criteria for raw materials, internally/externally manufactured components, or internally/externally finished products
  2. Packaging or labeling information, process, or materials.
  3. Process parameters
  4. Tools or consumables (i.e. wipes, gloves, shoe covers, etc.)
  5. Equipment or equipment settings
  6. Cleaning processes of the manufacturing environment or manufacturing equipment
  7. Locations for manufacturing, testing, sterilization, or warehousing
  8. Environmental conditions of manufacturing, testing, or storage,
  9. Control of monitoring processes for the manufacturing, testing, storage, or distribution environment
  10. Any change that can potentially impact form, fit, or function and the quality of the product.

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.


 

    • HOW TO AVOID MISTAKES DOING GMP TRAINING.

      1. We suggest evaluating your current personnel positions to determine which procedures, forms work instructions, and training requirements 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, 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.
      3. To download a free cGMP training procedure template sample in .pdf format, click here.  
      4. To download a cGMP training procedure template fully editable in MS Word format, ready to fill, and use according to your cGMP needs, click here.   
      5. To see the complete list of the most popular cGMP quality procedures templates, click here.

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

g

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

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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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