GMP for Engineers

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.

 

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

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