The Common Technical Document

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
• Ensuring right-first-time development

Who should Attend

• Formulation chemists
• Senior analytical chemists
• Registration staff (all levels)
• Technical services chemists
• Quality control directors
• Quality managers
• R&D project managers