Displaying 1–25 of 26 results for Justin Neway, Aegis Analytical
In a recent talk, Ajaz Hussain, former FDA Deputy Director of the Office of Pharmaceutical Science (OPS), reminisces about the Agency's 21st Century initiative and looks ahead to challenges yet to be addressed.
The draft guidance is a win-win-win: good for FDA, consumers, and manufacturers.
Implementing a new IT paradigm for on-demand data is as much an organizational issue as it is a technological one.
While U.S. drug products are of high quality, there has been an increasing trend towards manufacturing problems, resulting in recalls, disruption of operations and drug shortages. Companies are missing billions of dollars of potential additional revenue, and necessary medications are sometimes ...
When it comes to reducing technology transfer risk, the secret sauce is really process understanding. The desired state for manufacturing is a design based on a mechanistic understanding that provides real-time quality assurance (rather than expecting quality to be tested in).
Predictable outcomes lead to greater manufacturing efficiency and speed time to value.
Life-science companies that adopt quality by design (QbD) into their overall operations are expected to achieve the desired state of manufacturing. So concludes the Q10 document from the EMEA, US FDA, and the International Conference on Harmonisation of Technical Requirements for the ...
Process improvement and Quality by Design become practical realities only when the barriers to easily accessing and working with all the process data together are removed, and the team can spend its time instead on productive science-based collaboration. This is the best way to undertake the ...
In part two of a video interview taped at Interphex 2008, Justin Neway, CSO of Aegis Analytical discusses pharmaceutical process development, QbD, and manufacturing with Editor-in-Chief Agnes Shanley.
In this video interview taped at Interphex 2008, Justin Neway, CSO of Aegis Analytical discusses pharmaceutical process development, QbD, and manufacturing with Editor-in-Chief Agnes Shanley.
Aegis Analytical's Justin Neway goes into further detail on the necessity of process development and manufcturing being on the same team in this audio presentation.
Justin Neway, CSO of Aegis Analytical discusses pharmaceutical process development, QbD, and manufacturing.
Is the industry equipped for full-fledged QbD?
Critical to any PAT effort is having a single point of easy, on-demand access to all relevant data, in a context thats meaningful to diverse groups of users. But data must be presented in a way that facilitates the identification and understanding of cause-and-effect relationships. Justin Neway,...
Editor in Chief Agnes Shanley recaps the highlights of Interphex 2006.
This year's event builds upon the success of the 2005 show, with increases in both exhibitors and educational sessions.
FDA wants its drug investigators to go to a higher level. Can they get there? Will they really make a difference?
Powerpoint slides from Justin Neway, CSO of Aegis Analytical's podcast of the results of an AMR Survey on Quality by Design.
Justin Neway, CSO of Aegis Analytical discusses the results of an AMR Survey on Quality by Design.