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In-house Training Programme


Quality Data in the Marketing Authorisation Application

When What
08.30 – 08.45 h Welcome
08.45 – 09.45 h Quality Data in CTD Module 2 and Module 3
09.45 – 10.45 h CTD Modul 3 Quality Drug Substance – What is required?
10.45 – 11.15 h Coffee Break
11.15 – 12.15 h Advantage for the API Manufacturer (1): CEP
12.15 – 13.15 h Lunch Break
13.15 – 14.15 h Advantage for the API Manufacturer (2): ASMF
14.15 – 14.45 h Coffee Break
14.45 – 15.45 h CTD Module 2: Quality Overall Summary
15.45 – 16.30 h QP-Declaration in CTD Module 1: Auditing API Manufacturers
16.30 – 17.00 h Final Discussion
ca. 17.00 h End of Training Course
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 above agenda proposal 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.


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