The Common Technical Document is a course dedicated to the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
Key Topics
Quality by design (QbD), critical attributes and developing new product
Effective compilation of the Common Technical Document (CTD) and critical review of documentation using the CQA pyramid model
Identifying the extent of content expected by EU and US regulators
Compiling and submitting Module 3 (CTD) of your registration dossier
Managing the pharmaceutical and quality aspects of your developments and registration dossier in Europe and the US
Achieving the quickest turnaround of your submission
Meeting the legal framework and guidelines for the CMC/quality part of the dossier and links to GMP
