Displaying 1–25 of 52 results for Aegis Analytical

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Process Development and Manufacturing Need To Be One Team

(Article)

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

Accelrys Acquires Aegis Analytical Corp. for $30 million in Cash

(News)

New enterprise manufacturing process intelligence software capabilities expand Accelrys' footprint in downstream product development and commercialization operations.

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 ...

Life Sciences Manufacturers Face Data Challenge Despite Significant IT ...

(Whitepaper)

Aegis Analytical Corporation, in conjunction with Pharmaceutical Manufacturing Magazine, conducted a survey of pharmaceutical and biotech manufacturers in order to better understand current practices for gathering and analyzing manufacturing process data. This paper summarizes the key trends and ...

Aegis Analytical Corp.

(Product)

Software Suite Delivers Extended Data Platform to Third Party Applications

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,...

New Patterns for Quality

(Article)

Quality by Design is breathing new life into quality systems and process analytical technology.

Reviewing the Basics of Stats

(Article)

A quick check of the fundamentals will help you approach manufacturing analytics with the right statistical mindset.

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.

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.

Better Process Understanding Improves Quality, Lowers Risk

(Article)

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

Balancing Compliance with Economics: The New Role of Manufacturing

(Article)

As process manufacturers search for ways to trim costs and boost revenue – whether that be by increasing yield or speeding time to value – they can view the FDA’s inspections and PAT recommendations as opportunities to better understand manufacturing processes across the organization. Today’s IT ...

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).

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 ...

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.

Process Analytical Technologies 101

(Article)

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.

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.

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 ...

S-Factors: a Tactical PAT Kit

(Article)

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.

Collaborating for Quality by Design

(Multimedia)

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