Displaying 1–25 of 26 results for Justin Neway, Aegis Analytical

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Industry Thought Leaders Share Visions and Lessons about Quality for ...

(Article)

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.

FDA’s Process Validation Guidance Calls for Technology Solutions

(Article)

The draft guidance is a win-win-win: good for FDA, consumers, and manufacturers.

Putting Global Manufacturing Data at Your Fingertips

(Article)

Implementing a new IT paradigm for on-demand data is as much an organizational issue as it is a technological one.

How New Technologies Can Improve Compliance in Pharmaceutical and Biotech ...

(Whitepaper)

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 ...

Reducing Tech-Transfer Risk: Collaborative Data Access, Trending, Reporting, ...

(Article)

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).

Better Process Understanding Improves Quality, Lowers Risk

(Article)

Predictable outcomes lead to greater manufacturing efficiency and speed time to value.

Process Excellence: Five Critical Elements of Quality By Design

(Article)

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 ...

Achieving Manufacturing Process Excellence with Quality by Design, Design ...

(Whitepaper)

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 ...

Part Two: Justin Neway on Process Development, QbD and Manufacturing

(Multimedia)

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.

Justin Neway on Process Development, QbD and Manufacturing

(Multimedia)

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.

Collaborating for Quality by Design

(Multimedia)

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.

April 2008

Process Development and Manufacturing Need To Be One Team

(Article)

Justin Neway, CSO of Aegis Analytical discusses pharmaceutical process development, QbD, and manufacturing.

From the Editor: Confused About Quality?

(Article)

Is the industry equipped for full-fledged QbD?

On-demand Data Access and Analytics Enable Decisions for Process Excellence

(Article)

Critical to any PAT effort is having a single point of easy, on-demand access to all relevant data, in a context that’s 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,...

Interphex in Review: On India, China, PAT and E-Pedigrees

(Article)

Editor in Chief Agnes Shanley recaps the highlights of Interphex 2006.

Notes from Interphex

(Blog)

Interphex 2006 Preview: The Best of the “Phex”

(Article)

This year's event builds upon the success of the 2005 show, with increases in both exhibitors and educational sessions.

FDA's Pharmaceutical Inspectorate Searches for Higher Ground

(Article)

FDA wants its drug investigators to go to a higher level. Can they get there? Will they really make a difference?

Process Analytical Technologies 101

(Article)

Interphex Show Preview

(Article)

AMR Survey Results PowerPoint

Powerpoint slides from Justin Neway, CSO of Aegis Analytical's podcast of the results of an AMR Survey on Quality by Design.

Podcast: AMR Survey Results on Quality by Design

Justin Neway, CSO of Aegis Analytical discusses the results of an AMR Survey on Quality by Design.

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