GMPs for Equipment, Utilities and Facilities

GMP in-house Training Courses are an ideal solution for ten or more people and are very cost-effective. We come to you at a time and date to suit your organisation.

Please contact us if you are interested in a detailed offer.

The agenda proposal aside has been developed for an in-house training course (group of participants). If you are interested to participate as an individual person please check our list of GMP training courses and conferences.

Agenda Proposal

  Day 1
08.00 - 08.30 Welcome, Introduction
08.30 - 09.30 Technical regulations in the GMP world
09.30 - 09.45 Coffee break
09.45 - 10.45 Change Control, Deviation Management and CAPA in the GMP world
10.45 - 11.30 Risk Analysis and Risk Management in a technical environment
11.30 - 12.15 Lunch
12.15 - 13.15 Commissioning, Qualification and Re-qualification
13.15 - 13.45 Science- and Risk-based Qualification – cost-effective alternatives
13.45 - 14.00 Coffee break
14.00 - 15.00 Materials and Surfaces in a GMP environment
15.00 - 15.30 Questions and discussion

 

  Day 2
08.00 - 09.00 GMP Compliant Equipment Design
09.00 - 09.30 Cleanrooms and GMP Zone Concepts
09.30 - 10.00 GMP Cleanroom Requirements
10.00 - 10.15 Coffee-break
10.15 - 11.15 Upgrading, re-construction and renovation of GMP facilities
11.15 - 12.00 Lunch
12.00 - 13.00 Pharmaceutical Water Systems
13.00 - 14.00 Maintenance & Calibration
14.00 - 14.15 Coffee break
14.15 - 14.45 Impact of the new GMP thinking on Engineering
14.45 - 15.00 Wrap up and Discussion

 

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