GMP for Engineers
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GMP knowledge for the planning, qualification and maintenance of the pharmaceutical equipment and facilities
Learning units included:
12A: GMP Basics for Technology & Engineering
12B: From the Planning Stage to Functional Testing
12C: From Functional Testing to Handover
12D: Maintenance and Operational Support
12E: Design Principles and Technical Documentation
These learning units are also available separately. Please contact service@gmp-publishing.com.
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Test the free demo version now! |
Online Courses GMP:READY
Delivery time appr. 2-3 workdays
| Quantity | Unit price netto | Unit price incl. VAT |
|---|---|---|
| To 4 | €269.00 | €312.04 |
| From 5 | €249.00 | €288.84 |
| From 10 | €229.00 | €265.64 |
| From 20 | €209.00 | €242.44 |
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
Content
Unit 12A: 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 12B: 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 12C: 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 12D: 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 12E: 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.
Please note: After receipt of your payment it can take up to 2 working days until you receive the access data by e-mail.
Available downloads:
Summary of units 12.A-E
Related links to "GMP for Engineers"
Free demo version "Maintenance and Operational Support"- 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
€195.00 net
€345.00 net
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