GMPs for Equipment, Utilities and Facilities

Below is an example of a 3 day inhouse training course. We also offer this training as a 1 or 2 day course.
  Content Day 1
09.00 - 10.00 Introduction and regulatory requirements
10.00 - 11.00 Development of a maintenance system in the GMP environment
11.00 - 11.30 Coffee Break
11.30 - 13.00 A Risk-based approach to maintenance
13.00 - 14.00 Lunch
14.00 - 15.00 Organization of Maintenance
15.00 - 15.15 Short Coffee Break
15.15 - 16.45 GMP-compliant Calibration
16.45 - 17.00 Short Break
17.00 - 17.45 Maintenance of manufacturing equipment: examples
17.45 - 18.00 Discussion
 
  Content Day 2
08.30 - 09.30 Hygiene aspects in maintenance work
09.30 - 10.30 Case Study: Maintenance of an HVAC System
10.30 - 11.00 Coffee Break
11.00 - 12.30 Case Study: Maintenance of a pharmaceutical Water System
12.30 - 13.30 Lunch
13.30 - 14.30 “Maintenance 4.0” – Digital & Paperless
14.30 - 15.00 Discussion
16.30 - 16.40 Short Break
16.40 - 17.30 Qualification and Management of technical suppliers
17.30 - 17.45 Discussion
 
  Content Day 3
08.30 - 10.15 Pharmaceutical Water Systems
10.15 - 10.45 Coffee Break
10.45 - 12.00 Maintenance & Calibration
12.00 - 13.00 Lunch
13.00 - 14.15 Impact of the new GMP Thinking on engineering
14.15 - 14.45 Discussion

 

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