The Center for Professional Advancement, Burlingame, CA
August 6-7, 2007
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.
|
|