The Common Technical Document is a course dedicated to the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
The Common Technical Document covers topics such as:
- 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
- Ensuring right-first-time development
The Common Technical Document brings together:
- Formulation chemists
- Senior analytical chemists
- Registration staff (all levels)
- Technical services chemists
- Quality control directors
- Quality managers
- R&D project managers
The next Common Technical Document will be held on 12-13 Mar 2024.
