Maintenance and Calibration of Equipment in a GMP Environment

For any pharmaceutical manufacturer, proper maintenance and calibration of equipment is indispensable. That's why Biotech Training Facility offers this maintenance and calibration course.

1 day
Course fee
€ 945 (excl. VAT)

Short description

What can you expect from this course Maintenance and Calibration under GMP?

Comments of participants:

"very good content" , "very interactive"

Average score of previous Maintenance course: 9

During this course the theory will be alternated with workshops on frequency determination and on registration of maintenance and calibration of equipment in a GMP regulated environment.

The course is therefore very suitable for staff members of technical departments who work on a daily basis on maintenance and calibration and the registration of these activities, but also for validation/qualification staff members who set up the maintenance plan for the equipment.


To increase knowledge and awareness with regard to the following issues:

  • Why maintenance is necessary
  • What the GMP regulations state in terms of maintenance and calibration
  • Which requirements have to be met for a proper registration of maintenance and calibration activities
  • How to determine the right frequency for maintenance and calibration of various parts of equipment
  • What to do in case of deviations in calibrations and maintenance

Target group

Who should follow this Maintenance and Calibration training?

This course is suitable for everyone who is involved in calibration and maintenance under GMP, for example technical service, validation / qualification engineers, QC, operations staff and QA.



Welcome and introduction



• Equipment and facility: regulations, equipment life cycle, equipment qualification, the requirements for a facility and equipment
• Risk management: ICH Q9, how to make use of ICH Q9 in the different phases of the equipment life cycle, how to report risk assessments, FMEA
• Deviations: workflow, deviation and OOT, root cause investigation, impact assessment, CAPA
• GxP equipment maintenance: documentation and registration, deviations, training of service engineers



• Workshop: GxP equipment maintenance
• Workshop: risk assessment



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Interested in signing up a group of people for this course?

Please contact our Business Development team:
+31 (0)88 2830100

Need help? Have a question or a suggestion maybe?

Drop us a line below or call us on
+31 (0) 88 283 01 00.