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14 December 2016 09:00 - 15 December 2016 17:00, London, United Kingdom
Introduction
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
