Regulatory Assessment requirements of Quality by Design data
Online Training Id: PQMS-004
Geographical Region: Global
Level: Intermediate
Duration: 3 hrs
This course identifies the Principals of Regulatory Quality evaluation and shows the benefits of adding data derived from the Quality by Design process in to the Common technical Documentation dossier when seeking MAA for a generic or new product.
Learning Objectives:
This course will provide the measures necessary to be taken to ensure that the product meets the Quality Target Product Profile and the Regulatory requirements for assessment regardless of the development approach for the areas ;
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API
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Formulation
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Manufacturing process
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Control strategy
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Analytical Procedures
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Stability
Author:
John DR Jolley - FR Pharm S, FCQI CQP is a co-founder of Pharma Consult Global, a Pharmaceutical Consultancy providing technical consultancy and training European countries, Middle East, South Africa and the USA and involving International Pharmaceutical Experts from around the world. He is a pharmacist who has held positions in Clinical Research, Product Registration, Pharmaceutical Manufacturing, Quality Assurance, and General Management. He was Technical Director for Boehringer Ingelheim UK for 15 years before working in Technical consultancy. He is a practicing Qualified Person (QP) for pharmaceutical manufacturing, Distribution and Clinical Research organizations, and is an Industry representative on the EMA advisory committees for GMP/GCP. John has a degree in Pharmacy and has been awarded fellowships with the Royal Pharmaceutical Society and the Chartered Quality Institute.
John Dr Jolley FR PHARM S, FCQI CQP
