Senior Analytical Chemists Formulation Chemists Technical Services Chemists Registration staff (all levels) Quality Managers Quality Control Directors R & D Project Managers
Project Management/Collection of Critical Documents for Chemistry, Manufacturing and Control (CMC) for Global Registration (CTD) & Incorporate Quality by Design within the CTD
This course will cover the following topics:
WHY YOU SHOULD ATTEND
This two-day course will provide you with a clear understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of EU and USA. Furthermore, the course examines the requirements for Global roll out of the dossier to ROW regions including, LATAM, ASEAN, MENA and CIS territories.
You will increase your ability to manage all aspects of development of the CMC aspects of applications after two days of intensive lectures, group work, and discussion sessions, covering everything you need to know about compiling the chemistry and pharmacy section of your generic dossie
GBP EUR USD Standard 1399 1959 2182 Excluding VAT @ 20.00%