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FDA and Conformia Deliver Joint Presentation to Annual Regulatory and Compliance Symposium at Harvard
Date:8/30/2007

pharmaceutical manufacturing

-- Consequences pharmaceutical companies face in the present environment

-- The current state of the regulatory quality review process

-- The mutual goal for industry, society and regulators to reliably

produce high-quality products without extensive regulatory oversight

-- Benefits of the new QbD paradigm for both the FDA and the industry

About the CRADA Study

The CRADA study began in April 2006 as a preliminary study of nine companies and is due to expand to 25 companies. Focusing on understanding the current practices of pharmaceutical development and commercialization, the study is designed to align with the FDA's Current Good Manufacturing Practice (cGMP) initiative for the 21st century and the Critical Path initiative, of which QbD is a key component. The study is unique because it enables companies to openly share their concerns with the FDA without fear of ramifications.

The presentation is available on the Conformia website -- http://www.conformia.com

About Conformia

Conformia is the market leader and innovator in product/process lifecycle management (PPLM) software solutions for regulated process industries including life sciences and beverage alcohol. These solutions enable pharmaceutical companies to save significant time and money through major improvements in product/process development operations by creating central master active pharmaceutical ingredients and formulation databases across the lifecycle. Conformia's web-based enterprise software helps improve product quality, provides a platform for regulatory flexibility, decreases time to market, increases product / process operational effectiveness and streamlines tech transfer. Conformia is offered as an SAP-endorsed business solution for pharmaceutical development operations and beverage alcohol operations. Together SAP and Conformia are building a bridg
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SOURCE Conformia
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