SOURCE: Conformia

March 24, 2008 08:00 ET

Conformia and FDA Present How to Break Down Barriers in FDA Quality by Design Standards at 2008 INTERPHEX Conference

PHILADELPHIA, PA--(Marketwire - March 24, 2008) -


What:

Anjali Kataria, Founder and Chief Marketing Officer of Conformia Software, Inc., the leading provider of Product Process Lifecycle Management Solutions to the Pharmaceutical Industry, is co-presenting with Jon Clark, Associate Director at the U.S. Food and Drug Administration, the education session "Breaking Down Barriers for the FDA's Quality by Design" at the 2008 INTERPHEX conference. The session will cover recent research from Conformia's Cooperative Research and Development Agreement (CRADA) and will highlight the biggest challenges drug developers face when capturing, storing and retrieving scientific knowledge as they attempt to implement ICH Q8, Q9, Q10. Using the FDA's Quality by Design (QbD) initiatives as a backdrop, Kataria and Clark will offer insight into how pharmaceutical companies can improve how to access, track and leverage knowledge from research and development in order to produce higher quality submissions.

Where:

INTERPHEX 2008 North American Conference

Pennsylvania Convention Center, Philadelphia, PA

When: Wednesday, March 26, 10:15-11:15 a.m. EDT

Why:

Inside the complex organizations of pharmaceutical and biotech manufacturing, experimental data and conclusions from research and development are often buried in multiple silos of data across the product/process lifecycle. As a result, the details behind this data -- the who, what, where, why and how of development -- often remain a mystery. Traceability and reuse become complex. In light of new FDA guidelines for QbD, namely the International Conference on Harmonization (ICH) Q8 and Q9, these organizations need to resolve these data issues and satisfy these industry requirements for pharmaceutical development and quality risk management.

Kataria will present how Conformia addresses these pharmaceutical industry challenges and will be available during the conference for press interviews. To schedule a briefing or a teleconference before or after the event, please contact conformia@schwartz-pr.com.

About Conformia

Conformia Software is the leading provider of product/process lifecycle management (PPLM) software solutions to Life Sciences. Conformia solutions enable companies to save significant time and money through major improvements in product/process development operations, while modernizing the core product/process lifecycle knowledge. Conformia's solutions are all browser based, built on modern SOA and JAVA J2EE. The company's solutions include a platform for product/process lifecycle management (PPLM) as well as business applications for each major area of the product and process lifecycle, which help enhance operational visibility and traceability. Conformia offers an SAP-endorsed business solution and together, SAP and Conformia are building a bridge to support the lifecycle from development to manufacturing. For more information, go to www.conformia.com.

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