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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

Lieferzeit 2-3 Werktage

Menge Stückpreis netto Stückpreis inkl. MwSt.
bis 4 288,05 € 308,21 €
ab 5 265,80 € 308,21 €
ab 10 243,56 € 308,21 €
ab 20 221,32 € 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!

 

Weitere Informationen

Summary of units 12.A-E

Free demo version "Maintenance and Operational Support"

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Die mit einem * markierten Felder sind Pflichtfelder.

  • 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

 

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