ECA - GMP meets Development

Art-No.: A-999
Date: 13 - 15 June 2018

Price: EUR 380,-

The Conference folder includes the following topics:

No. Topic Summary Pages
12627Global GMP Requirements from Phase 1 to Scale-up and Transfer024
12628IMP´s in the context of ICH Q8, Q9 and Q10034
12629Analytical Development035
12630Packaging and Supply of Clinical Trial Materials033
12631IMP-Manufacturing: how much Qualification and Validation is needed?040
12632Change Control for IMPs 015
12633Interactive Session: Important Documents in Pharmaceutical Development037
12634The FDA Pre-Approval Inspection (PAI)050
12848Case Study: How to implement a cleaning validation in pharmaceutical development022
13143Case Study: How to handle Deviations in an R&D Environment030
13144The GMP/GCP Interface036
13145The Role of the QP in Pharmaceutical Development and IMP Release032
13146Workshops011

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