ECA - GMP meets Development

Art-No.: A-999
Date: 10 - 12 May 2017

Price: EUR 380,-

The Conference folder includes the following topics:

No. Topic Summary Pages
12628IMP´s in the context of ICH Q8, Q9 and Q10032
12629Analytical Development036
12630Packaging and Supply of Clinical Trial Materials032
12631IMP-Manufacturing: how much Qualification and Validation is needed?036
12632Change Control for IMPs 015
12633Interactive Session: Important Documents in Pharmaceutical Development031
12634The FDA Pre-Approval Inspection (PAI)059
12848Case Study: How to implement a cleaning validation in pharmaceutical development019
13143Case Study: How to handle Deviations in an R&D Environment023
13144The GMP/GCP Interface035
13145The Role of the QP in Pharmaceutical Development and IMP Release031
13146Workshops057

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