A fundamental grasp of GMP requirements is a critical asset. This one day course provides an overview of the current EudraLex Volume 4, Part II GMP regulations as applied to Active Substances used as starting Materials in Medicinal Products for Human and Veterinary use. A practical exercise is included to discuss common deficiencies noted by EMA, MRHA and FDA during regulatory inspections.
Good Manufacturing Practice (GMP) for APIs
4 April 2011, Nottingham, United Kingdom
Introduction
Venue
BioCity Nottingham
Innovation Room, BioCity Nottingham, Pennyfoot Street, Nottingham, NG1 1GF, United Kingdom
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Organised by
PMcG Consulting
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