Basic GMP Training Qualification/Validation

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

08.30 - 08.45 Welcome and Introduction of Participants
08.45 - 09.45 Basic Items of Qualification - Guidelines, Glossary
09.45 - 10.15 Validation Master Plan
10.15 - 10.45 Break
10.45 - 11.15 Risk Analysis
11.15 - 12.00 User Requirement Specification (URS), Functional Design Specification (FDS), Design Qualification (DQ)
12.00 - 13.00 Lunch
13.00 - 13.15 FAT/SAT
13.15 - 13.45 Installation Qualification (IQ)
13.45 - 14.15 Operational Qualification (OQ), Performance Qualification (PQ)
14.15 - 14.30 Break
14.30 - 15.15 Workshop
15.15 - 15.45 Presentation and Discussion of Workshop Results
15.45 - 16.15 Process Validation
16.15 - 16.45 Maintaining the Validated Status

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