Dr Moheb Nasr, Director of the Office of New Drug Quality Assessment (ONDQA) in FDA’s Center for Drug Evaluation and Research gave a presentation about the progress and the challenges of FDA´s Quality Initiatives at the European API Conference in Barcelona, Spain, from 27-29 October 2010. This presentation was videotyped.
Dr Nasr explains the move from traditional manufacturing with the “3 batch validation approach” to a modern approach of manufacturing and controls (e.g. by using Real Time Release Testing). He also explains the advantages of continuous manufacturing compared to batch manufacturing.
In addition to the presentation of Dr Nasr a second presentation was videotyped. Francois Vandeweyer, Director Global Compliance at Janssen Pharmaceutica, gave a presentation about the ICH Q7 "How to do Guide" (we already reported about this presentation in our GMP News).
The video presentations (Webcasts) are available for free on the conference webpage for the 14th European API Conference which will take place in Munich, Germany, from 16-18 November 2011. The European API Conference is organised by APIC/CEFIC and has become Europe´s most important API Conference in the field of GMP and regulatory compliance. APIC Members as well as ECA Members receive a discount on the registration fee.
Please click here to see the video presentations.