Markus Multhauf
Consultant Pharmaceutical Engineering
Referierende
Nikolaus Ferstl
Facility Engineering Services
Dr Johannes Krämer
formerly CSL Behring
Fritz Röder
Merck
Highlights
- Risk-based Maintenance & Development of a Maintenance Plan
- Calibration and Documentation in the Pharmaceutical Industry
- Handling Repairs and Replacements incl. Hygiene Aspects
- Case Studies (Water, HVAC, Equipment) + “Maintenance 4.0” (Digital & Paperless)
Zielgruppe
This course is designed for professionals responsible for planning, organising, and performing maintenance and calibration activities in pharmaceutical and related manufacturing plants. It is equally relevant for service providers who execute maintenance and calibration on-site and need to ensure their work and documentation meet GMP expectations.
Zielsetzung
This course aims to explain how GMP requirements for maintenance and calibration can be met in day-to-day operations without losing sight of cost and efficiency constraints. Participants will learn what makes maintenance and calibration in a GMP environment fundamentally different from other industries, and how to translate regulatory expectations (e.g., key requirements from US and EU GMP frameworks) into a robust, inspection-ready maintenance and calibration system.
The course will cover how to design and operate such a system: setting up a suitable maintenance structure, defining responsibilities and workflows, and ensuring that operational maintenance is performed in a controlled and hygienic manner. Particular focus is placed on risk-based planning, including how maintenance and calibration intervals are established and justified, and what actions are required when results or acceptance criteria are not met.
A further key objective is to enable participants to create GMP-compliant documentation, ensuring traceability, appropriate review (e.g., double-check principles), and contractor oversight. Practical examples and case scenarios will be used to connect regulatory expectations with real maintenance challenges, helping participants implement reliable processes that protect product quality, patient safety, and plant availability.
The course will cover how to design and operate such a system: setting up a suitable maintenance structure, defining responsibilities and workflows, and ensuring that operational maintenance is performed in a controlled and hygienic manner. Particular focus is placed on risk-based planning, including how maintenance and calibration intervals are established and justified, and what actions are required when results or acceptance criteria are not met.
A further key objective is to enable participants to create GMP-compliant documentation, ensuring traceability, appropriate review (e.g., double-check principles), and contractor oversight. Practical examples and case scenarios will be used to connect regulatory expectations with real maintenance challenges, helping participants implement reliable processes that protect product quality, patient safety, and plant availability.
Programm
Maintenance System & Organisation
- GMP-Requirements & advice from guidelines and standards
- Planning maintenance during the qualification phase
- Development of a maintenance plan and schedule
- System Impact (priority, importance, ranking)
- Execution of maintenance, flowcharts
- Inventory of equipment, HVAC, utilities
- Controlling limits and ranges, strategy for setting limits
- Handling of repairs and replacements, determining spare part requirements
- GMP-compliant documentation, paper based vs. electronic solutions
- GMP-Logbook, SOP´s, Change Control
A Risk-based Approach to Maintenance
- Internal Versus External Maintenance
- Are suppliers’ instructions for maintenance sufficient?
- Establishing maintenance items by risk analysis
- Determination of adequate materials to use
- Evaluation of available GMP documentation to define intervals
- Deviations, CAPAs, Logbooks
- Cost savings
GMP-compliant Calibration
- Structure of a GMP-compliant calibration system
- Traceability
- Requirements for measuring devices
- Uncertainty and how to avoid errors
- Execution of calibration – an example
- Calibration certificates and documentation
- Determination of calibration intervals
Hygiene Aspects in Maintenance Work
- Requirements for tools and auxiliary materials
- Typical weak points in maintenance work
- Sources of contamination: Maintenance staff; tools and auxiliary devices
- Restoring Operational Readiness
- Case study 1: Use of ladders in cleanrooms
- Case study 2: Wipe mop, wash-machine, cleaning water
- Case study 3: Oil sealing for stainless steel surfaces in cleanrooms
Case Study: Maintenance of a Pharmaceutical Water System
- Construction of water systems and components requiring maintenance
- Spare parts, intervals
- Special technical features for maintenance and repair
- Ozone and UV lamps
- Seals and Hoses
- Rouging
- IT Security, Remote Maintenance and Lifecycle
- Vibration analysis, thermography, ultrasonic testing
Case Study: Maintenance of an HVAC System
- Fundamentals and requirements for an HVAC System
- Main parameters in a cleanroom
- Test procedures and measurement methods
- Execution of maintenance, checklists
- Case study, examples
Maintenance of Manufacturing Equipment: Examples
- Special requirements and tips and tricks
- Pumps
- Vessels
- Filling Equipment
“Maintenance 4.0” – Digital & Paperless
- Case study CSL: implementation of a paperless maintenance system
- Usage of predictive maintenance tools
- Downtime reduction & cost savings
Weitere Informationen
Technical Requirements
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Fees (per delegate, plus VAT)
Non-ECA Members EUR 2,090
ECA Members EUR 1,890
APIC Members EUR 1,990
EU GMP Inspectorates EUR 1,045.- per delegate plus VAT
The conference fee is payable in advance after receipt of invoice. VAT is reclaimable.
ECA Members EUR 1,890
APIC Members EUR 1,990
EU GMP Inspectorates EUR 1,045.- per delegate plus VAT
The conference fee is payable in advance after receipt of invoice. VAT is reclaimable.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
The official conference language will be English.
You cannot attend the Live Event?
Many of the training courses and conferences are also available as recordings. You may watch these any time “on demand” on our web server. It is uncomplicated and doesn’t require any software – you simply watch the videos in your browser. All available recorded events can be found at www.gmp-compliance.org/recordings.
Many of the training courses and conferences are also available as recordings. You may watch these any time “on demand” on our web server. It is uncomplicated and doesn’t require any software – you simply watch the videos in your browser. All available recorded events can be found at www.gmp-compliance.org/recordings.
Contacts
Questions regarding content:
Dr Robert Eicher, +49 6221 84 44-12, eicher@concept-heidelberg.de
Questions regarding organisation:
Nicole Bach, +49 6221 84 44-22, nicole.bach@concept-heidelberg.de
Questions regarding content:
Dr Robert Eicher, +49 6221 84 44-12, eicher@concept-heidelberg.de
Questions regarding organisation:
Nicole Bach, +49 6221 84 44-22, nicole.bach@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 13 April 2027, 09:00-17:15 h
Wed, 14 April 2027, 09:00-16:15 h
All times mentioned are CEST.
All times mentioned are CEST.
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager"
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E-Mail: info@concept-heidelberg.de
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