GMP培训.

Eudralex - 卷 4 良好的制造实践 (GMP)

 

WEB-based

 

程序:

 GMP的基本原则    

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

 GMP检查过程 

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

 

描述

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.

 

价格

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, 工程, 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

评估

在每个模块的末尾提供了多项选择和真/错误评估.

学员将有 3 尝试成功完成每个评估的尝试.

 

期间

单个会话中不必完成模块, 该模块将从受训者离开的地方恢复. 你会从 1 一周 12 购买之日起完成课程的月份.

 

认证

成功完成课程后，学员将可以选择打印或保存符合监管GMP要求的个性化培训证书.

买

购买访问权限 1 学员, 单击“立即注册’ 按钮并关注结帐过程. 您将收到一封具有登录详细信息的自动电子邮件.

购买一组学员的访问权限, 单击“立即注册’ 按钮, 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.

或者, 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.

 

更多信息

If you would like to ask questions, please email [email protected]

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