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Preparing the Quality Module of the CTD

5-week online course | 2 hours per week

4 November - 6 December 2019

Online Academy

Course Content Summary

Module 1: CMC in the Drug Development Programme

Module 2: Module 3 & Quality Overall Summary

Module 3: Preparing the Drug Substance section of the application

Module 4: Essential information from API suppliers

Module 5: Meeting manufacturing and inspection requirements

Module 6: Writing the section on manufacture of the drug product and process validation

Module 7: Writing the sections on control of the finished product

Module 8: Module 7 Specifications

Module 9: Stability Section

Module 10: Pharmaceutical Packaging