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.
Objectives
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.
Programme
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
Case study CSL: implementation of a paperless maintenance system
Usage of predictive maintenance tools
Downtime reduction & cost savings
Further Information
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.
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.
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.
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.
Testimonials
