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GMP for Engineers

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GMP knowledge for the planning, qualification and maintenance of the pharmaceutical equipment and facilities

Learning units included:

12 A: GMP Basics for Technology & Engineering
12 B: From the Planning Stage to Functional Testing
12 C: From Functional Testing to Handover
12 D: Maintenance and Operational Support
12 E: Design Principles and Technical Documentation

These learning units are also available separately. Please contact service@gmp-publishing.com.

Test the free demo version now!

Online Courses GMP:READY

Delivery time 2-3 Workdays

Quantity	Unit price netto	Unit price incl. VAT
To 4	€269.00	€320.11
From 5	€249.00	€296.31
From 10	€229.00	€272.51
From 20	€209.00	€248.71

Description

Customer reviews

Target Group

Technical Requirements

Other

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What do technicians and engineers have to do with GMP rules?

For example, they are involved in the following tasks:

Planning and construction of the ventilation system
Maintenance of water treatment plants
Calibration of measuring sensors

Technicians and engineers are therefore also jointly responsible for the quality of medicines and are committed to GMP-compliant work!

Content

Unit 12 A: GMP Basics for Technology & Engineering

Introduction
Legal Fundamentals
The Engineer's Language
Life Cycle
Qualification and Validation
Planning
GMP-Compliant Design
Installation & Commissioning
Produktion
Key Points at a Glance

Unit 12 B: From the Planning Stage to Functional Testing

Introduction
GMP Requirements for Planning Phase
User Requirement Specifications (URS)
Functional Design Specification/Odder
GMP Risk Analysis
Design Qualification
Factory Acceptance Test (FAT)
Site Acceptance Test (SAT)
Key Points at a Glance

Unit 12 C: From Functional Testing to Handover

Introduction
Qualification Fundamentals
Documentation of the Qualification
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Qualification of Computerised Systems
Handover to the Operations
Key Points at a Glance

Unit 12 D: Maintenance and Operational Support

Introduction
Preventive Maintenance
Calibration and Recalibration
Requalification
Deviations, Changes and CAPAs
GMP Compliant Documentation
Traceability
Limitation of Liabilities
Key Points at a Glance

Unit 12 E: Design Principles and Technical Documentation

Introduction
Layout Principles
Cleanroom Classification
Walls, Ceilings, Floors
Hygienic Design
Materials
Technical Documentation
Key Points at a Glance

You can find a detailed table of contents by clicking on the individual course units.

The course units can be purchased as a complete package or individually.

Processing time per learning unit: 30-45 minutes
Personal certificate after passing the final test

Your Advantages:

fast familiarization with the topic of GDP within approx. 2 hours (corresponds to one day of external training)
time- and place-independent training
printable personal certificate
training content can be used for 12 months (initial training as well as additional follow-up training possible)
automatic updates in the case of legal changes
content and terminology comply with the obligation to provide evidence in accordance with Article 7(4) of Directive 2003/94/EC.

>>> Learn more about GMP:READY

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Available downloads:

Summary of units 12.A-E

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Related links to "GMP for Engineers"

Free demo version "Maintenance and Operational Support"

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Customer reviews can be made anonymously and will be published in our webshop after verification.

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Project managers
Technicians and engineers responsible for planning, operation or for qualification, operators, quality assurance

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GMP:READY is a browser-based e-learning tool. You can easily access the e-learning online via username and password.
Please note: The login data will be set up for the named person in the delivery address.

The course is displayed in the browser via FIT² Coach.

The following system requirements apply:

Operating systems:

Windows
Mac
Linux

Browsers:

Microsoft Internet Explorer 10 or 11
Google Chrome (from version 52)
Mozilla Firefox (from version 47)
Microsoft Edge (Version 20 or higher)
Safari (from version 9)
or other HTML5-enabled browsers

Read here the Data Privacy Statement of our e-learning partner.

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The GMP Compliance Adviser was used as the basis for these learning units. Some of the texts and examples were adopted.

You would like to train a larger number of employees with this tool?
We are pleased to provide an individual offer tailored to your specific requirements!

Please contact
Annette Crawford
crawford@gmp-publishing.com
Phone: +49 7622 66686-74