Art-No.: A-999
Date: 13 - 15 June 2018
Price: EUR 380,-
No. | Topic | Summary | Pages |
12627 | Global GMP Requirements from Phase 1 to Scale-up and Transfer | 0 | 24 |
12628 | IMP´s in the context of ICH Q8, Q9 and Q10 | 0 | 34 |
12629 | Analytical Development | 0 | 35 |
12630 | Packaging and Supply of Clinical Trial Materials | 0 | 33 |
12631 | IMP-Manufacturing: how much Qualification and Validation is needed? | 0 | 40 |
12632 | Change Control for IMPs | 0 | 15 |
12633 | Interactive Session: Important Documents in Pharmaceutical Development | 0 | 37 |
12634 | The FDA Pre-Approval Inspection (PAI) | 0 | 50 |
12848 | Case Study: How to implement a cleaning validation in pharmaceutical development | 0 | 22 |
13143 | Case Study: How to handle Deviations in an R&D Environment | 0 | 30 |
13144 | The GMP/GCP Interface | 0 | 36 |
13145 | The Role of the QP in Pharmaceutical Development and IMP Release | 0 | 32 |
13146 | Workshops | 0 | 11 |