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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 €259.00 €308.21
From 5 €239.00 €308.21
From 10 €219.00 €308.21
From 20 €199.00 €308.21
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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


Test the free demo version now!

 

Available downloads:

Summary of unit 12.A "GMP Basics for Technology & Engineering"

Summary of unit 12.B "From the Planning Stage to Functional Testing"

Summary of unit 12.C "From Functional Testing to Handover"

Summary of unit 12.D "Maintenance and Operational Support"

Summary of unit 12.E "Design Principles and Technical Documentation"

Free demo version "Maintenance and Operational Support"

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

 


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.


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

 

€210.00 net

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