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.
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.
RECOMMENDATIONS TO AVOID MISTAKES WHEN YOU INITIATE A GMP TRAINING EFFORT.
- 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.
- 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.
- To download a free cGMP training procedure template sample in .pdf format, click here.
- 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.
- 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.
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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.