E-Learning GMP:READY | Specialist Knowledge GMP for Engineers
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Produktart
E-Learning
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.
Free demo version "Maintenance and Operational Support"
Please note: After receipt of your payment it can take up to 2 working days until you receive the access data by e-mail.
| Anzahl | Stückpreis |
|---|---|
| Bis 4 |
305,00 €*
|
| Bis 9 |
285,00 €*
|
| Bis 19 |
265,00 €*
|
| Ab 20 |
245,00 €*
|
* netto zzgl. MwSt.
Produktinformationen
Why are GMP rules important for technicians and engineers?
Technicians and engineers play a key role in ensuring compliance with Good Manufacturing Practice (GMP) standards. They are involved in critical activities such as:
- planning and construction of ventilation systems,
- maintenance of water treatment plants,
- calibration of measuring sensors.
Therefore, they are jointly responsible for the quality of medicines and must ensure that their work complies with GMP standards.
Your advantages:
- Fast familiarization with GMP topics in approx. 2 hours,
- time- and location-independent online training,
- printable personal certificate,
- 12-month access for initial and follow-up training,
- automatic updates in case of legal changes,
- content compliant with Article 7(4) of Directive 2003/94/EC.
The Author
This e-learning course was developed with the collaboration of Dipl.-Ing. Andreas Nuhn (D & B Pharmadesign GmbH).
The performance is checked directly:
- You'll get a personal certificate after passing the final test.
What you need to use our portals: Technical requirements
Learning Components
- Introduction
- Legal Fundamentals
- The Engineer's Language
- Life Cycle
- Qualification and Validation
- Planning
- GMP-Compliant Design
- Installation & Commissioning
- Production
- Key Points at a Glance
- Introduction
- GMP Requirements for Planning Phase
- User Requirement Specifications (URS)
- Functional Design Specification/Order
- GMP Risk Analysis
- Design Qualification
- Factory Acceptance Test (FAT)
- Site Acceptance Test (SAT)
- Key Points at a Glance
- 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
- Introduction
- Preventive Maintenance
- Calibration and Recalibration
- Requalification
- Deviations, Changes and CAPAs
- GMP Compliant Documentation
- Traceability
- Limitation of Liabilities
- Key Points at a Glance
- Introduction
- Layout Principles
- Cleanroom Classification
- Walls, Ceilings, Floors
- Hygienic Design
- Materials
- Technical Documentation
- Key Points at a Glance
Weitere Details
Zertifizierte Datensicherheit: Datenschutzregelungen nach §§ 5, 9, 11 BDSG liegen vor und können bei Bedarf abgestimmt werden. Lesen Sie hier die Datenschutzerklärung unseres E-Learning-Partners.
Einfacher Online-Zugriff ganz ohne Installation auf Ihrem Computer. Die Kursanzeige erfolgt online im Browser über die Plattform FIT² Coach.
Der SCORM-Standard wird unterstützt: Sie können die Lerneinheiten auch direkt in Ihr unternehmenseigenes Learning Management System (LMS) einbinden (SCORM 2004 4th Edition/3rd Edition/2nd Edition, SCORM 1.2).
Zielgruppe
- Project managers
- Technicians and engineers responsible for planning, operation or for qualification, operators, quality assurance
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