Displaying 26–50 of 52 results for Aegis Analytical
Predictable outcomes lead to greater manufacturing efficiency and speed time to value.
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).
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.
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.
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.
Justin Neway, CSO of Aegis Analytical discusses pharmaceutical process development, QbD, and manufacturing.
Data historians and manufacturing process intelligence platforms aim to improve manufacturing efficiency.
Quality by Design is breathing new life into quality systems and process analytical technology.
Is the industry equipped for full-fledged QbD?
Software Suite Delivers Extended Data Platform to Third Party Applications
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,...
Werum has launched new versions of its PAS-X Pharma and PAS-X Biotech software suites.
Editor in Chief Agnes Shanley recaps the highlights of Interphex 2006.
When is an aspirin tablet like a yacht? According to Jack Carroll, the answer to this riddle lies in five S-factors: Staff, Select, Strategize, Spend and finally, Supplant a GMP-tested product line with its parallel PAT counterpart.
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.