Emerson will once again be presenting and exhibiting at IFPAC in Balitmore, MD this year as we continue to expand our products and services for PAT. On Monday (at last word) I'll be giving a presentation on how we integrated PAT Methods using the synTQ Data Management product from Optimal Industrial Automation Ltd. seamlessly into Syncade recipes. Tuesday afternoon, David Rehbein from the Life Science Industry Group will be presenting on Batch Analytics, our newest product soon to be released, and how it provided real time quality prediction on bioreactors. Our Real-Time Release Solutions booth, will be there so if you want to see Syncade operating with PAT Methods sequenced into recipes to control an operating formulation tank be sure to stop by Booth 300. See you there!
IFPAC - Day 1 Janet Woodcock, FDA Director
This conference continues to grow with over 600 attendees from over 25 countries. Janet Woodcock, Director of the FDA provided a ad hoc keynote that she described as "from the heart. She was upbeat as she walked through a short history of the QbD and quality initiavtives at the FDA and mentioned that she had walked throught the technology exhibits prior to her talk and was gald to "See its starting to take hold". She made a clear distinction that it's FDA job to make sure its (manufacturing) done right but industries job to do it right. Both sides have a responsibility and although lots of progress has been made she believes that the there's still more to do to get the mximum results. She further emphasized the agencies approach to inspections under the new quality framework:
She pointed out that most quality failures are not due to control strategy but when things went wrong the manufacturer did not intervene. On the inspection side she also pointed the recently submitted proposal to congress to entact a "generics" fee. The FDA is underfunded and understaffed to inspect foreign manufacturing operations and the fee would provide the needed revenues to create a level inspection playing field. In my opinion, with greater inspections we will expect a greater number of recalls (whch is good for public health) and even more drug shortages with the expansion of healthcare. Is unclear what the fee will be but regardless it will impact the costs of generics which will be passed on to the consumer.