formation GMP.

EudraLex – Volume 4 Bonnes Pratiques de Fabrication (GMP)

WEB-based

Programme:

 Principes de base des BPF    

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

 Processus d'inspection des BPF 

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

La description

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.

Prix

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, ingénierie, quality and warehouse personnel

contractors

cleaners

What’s covered?

The module covers:

Getting facility design right, from the start

Validating processes

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

Assessment

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.

Durée

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.

Certification

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.

Buy

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.

System requirements

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.

Plus d'information

If you would like to ask questions, please email head_office@nbscience.com

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