EudraLex – Volume 4 Buenas Prácticas de Fabricación (GMP)
Principios básicos de GMP Introduction to the training course Quality management Sanitation and hygiene Qualification and Validation Complaints and recalls Contract production and analysis Self-inspection and Quality Audits Personnel Premises Equipment Materials Documentation Good Practices in Production and Quality Control Sterile production Active Pharmaceutical Ingredient
Proceso de inspección GMP Introduction The role of the inspector Preparation for an inspection Types of GMP inspection The inspection
GMP training description
Basic regulatory requirements for medicinal products and active substances
This e-Learning module provides a high level introduction to the 10 Golden Rules of Good Manufacturing Practice (GMP). Use the Golden Rules of GMP outlined in this e-Learning module to help drive your day-to-day operations. Keep them in mind whenever you make decisions that have GMP implications.
This module is included in some of our GMP bundles, but can also be taken separately.
485 Euros per person
Who should complete this package?
This entry level module is ideal for new starters, annual GMP training and/or formalising existing working knowledge.
It is suitable for:
those new to GxP regulated industries
operators and floor staff including manufacturing, engineering, quality and warehouse personnel
The module covers:
Getting facility design right, from the start
Writing good procedures and following them
Identifying who does what
Keeping good records
Staff development and training
Practicing good hygiene
Maintaining facilities and equipment
Building quality into the whole product life cycle
Performing regular audits
A multiple choice and True/False assessment is presented at the end of each module.
The trainee will have 3 attempts to successfully complete each assessment.
A module doesn’t have to be completed in a single session, the module will resume from where the trainee left off. You will have from 1 week to 12 months from the date of purchase to complete the course.
After successful completion of the course the trainee will have the option of printing or saving a personalised training certificate that meets regulatory GMP requirements.
To purchase access for 1 trainee, click the ‘register now’ button and follow the checkout procedure. You will receive an automated email with login details.
To purchase access for a group of trainees, click the ‘register now’ button, change the quantity required and follow the checkout procedure. You will receive an automated email requesting the list of students. Once you supply this, we’ll setup the logins and the trainees will receive their login details via email.
Alternatively, please contact us to arrange a proposal for a large group of trainees if you would prefer to purchase via invoice rather than purchase online.
The online training modules provided on this site are accessed through a web browser on your PC. Check that you have the correct system setup to run the modules.
How it works
To purchase and use an eLearning module, click on the ‘register now’ button and complete the check out process, paying via Paypal or a credit card or bank transfer.
You will receive an automated email with a purchase receipt and your login details and you’ll then be able to commence the course.
If you would like to ask questions, please email firstname.lastname@example.org