CMC Submissions in CTD Format
This course is not currently scheduled. Click on the Notify Me button to the left to be notified when it is scheduled.
This course is available as a client site course. Please click here for more information.
Who Should Attend
This course is intended for all personnel in pharmaceutical
companies especially those in:-
Regulatory Affairs
- Chemistry and Analytical Departments
- Pre-formulation
- Pharmaceutical Development
- QA/QC for the CMC section of the NDA/CTD
It is recommended that you have at least one year
experience in either regulatory affairs, chemistry, analytical,
QA/QC or pharmacy department or pharmaceutical
development to fully benefit from this course.
Description
This course will provide an in depth review of the
chemistry, manufacturing and controls (CMC)
requirements for development and ultimate submission
to the FDA and European regulatory bodies in the new
drug application (NDA). Emphasis will be placed on
current FDA, European and ICH requirements for the
filing of the quality section of the CTD for manufacturing,
analytical, sterility and stability issues as they apply to the
drug substance and drug product. In addition, details on
supplemental applications for changes to an NDA will
be presented focusing on SUPAC requirements.