SAP sponsored an industry Webcast for discussion of “Making Manufacturing Work More Efficiently.” The hour long forum featured three industry experts who discussed various aspects of how Compliant Manufacturing Operations provide a continuous improvement framework to improve quality, ensure compliance at a lower risk and lower manufacturing costs. OAKBROOK TERRACE, IL, June 28, 2009 /24-7PressRelease/ — SAP sponsored an industry Webcast for discussion of "Making Manufacturing Work More Efficiently." The hour long forum featured three industry experts who discussed various aspects of how Compliant Manufacturing Operations provide a continuous improvement framework to improve quality, ensure compliance at a lower risk and lower manufacturing costs.
Chris McNally, Arbour Group Executive Vice President was one of the industry experts. He discussed the "State of the Union: Life Science Manufacturing Compliance. He noted that key factors that will impact manufacturing compliance going forward are (1) a new presidential administration and FDA Commissioner, (2) expanded powers granted to the FDA by Congress and (3) more frequent enforcement of executive accountability provisions contained in existing regulations, i.e., individual liability. Regarding executive accountability McNally noted that regulations state that management with executive responsibility "shall ensure that the quality policy is understood, implemented and maintained at all levels of the organization." Suggested actions to ensure ongoing compliance included:
– Replacement of orphaned, disparate compliance reporting systems with holistic dashboards
– Adoption of industry standards to reduce variability
– Use of pre-configured software and pre-written validation packages that embody industry best practices
Overall, there is an expectation that enforcement will have a higher priority within the FDA and other regulatory agencies. To register for a free recast of this discussion click here.
About Arbour Group
Arbour Group LLC is a leading provider of regulatory products and services for pharmaceutical, medical device and biotechnology companies worldwide.
Arbour Group’s regulatory products include packaged validation protocols that help clients ensure that key enterprise software solutions are functional and in compliance with applicable regulations to minimize business risk. Regulatory services are based on a results-oriented software testing process that not only assures compliance and functionality, but also responds competitively to the needs of customers by ensuring product quality and reliability.
The Arbour Advantage is the combination of offerings that are designed to help regulated companies harmonize compliance efforts across diverse business software systems, geographically dispersed facilities and complex regulatory environments.
Arbour Group has been lowering the cost of compliance since 1990 for over 100 multinational companies with a global presence including United States offices in California, Illinois, and New Jersey, along with facilities in Dublin, Ireland and Dubai, U.A.E.
For more information, contact Arbour Group at http://www.arbourgroup.com.
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