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.  

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

You can establish your training program using a cGMP training procedure template or a  Training Management System Software.

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.

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.

Get a full template training procedure

Moreover, you can use free software applications to handle your Training Management System (eTMS) and facilitate the process when is necessary a GMP Training.

    • 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 GMP TRAINING, 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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