This course will cover the following topics:
- Development, analytical, formulation and quality experts to contribute to the effective compilation of CTD and allow effective review of documentation requiring agreement by regulators
- Drive full understanding of Quality by Design, Critical Attributes and developing new product using the CQA Pyramid model
- Compile and submit Module 3 (CTD) of your registration dossier
- Identify development needs for applications taking a “right first time” development approach and utilizing QBD
- Identify extent of content expected by EU and US regulators
- Provide practical experience and examples
- Achieve the quickest turnaround of your submission
- Deal effectively with your internal and external clients
- Manage the Pharmaceutical Development and Quality aspects of your developments and registration dossier in Europe and US
- Ensure all data needed has been collected in efficient manner
- Ensure Right First Time development
- Meet the legal framework and guidelines for the CMC/ Quality part of the dossier, and links to GMP
- Incorporate Quality By Design into your developments
