BiotechBistro Forums Tag: lean compliance

BiotechBistro Forums Tag: lean compliance http://biotechbistro.com/forum/tags/lean-compliance The Business of Biotechnology en-US Mon, 06 Feb 2012 09:49:45 +0000 bbpress 1.0-alpha-4 <![CDATA[Search]]> q http://biotechbistro.com/forum/search.php javellan on "Cerulean Named as IRO in US Consent Decree" http://biotechbistro.com/forum/topic/cerulean-named-as-iro-in-us-consent-decree#post-201 Tue, 06 Sep 2011 09:10:07 +0000 javellan 201@http://biotechbistro.com/forum/ Cerulean Associates LLC has been chosen as the independent review organization (IRO) for a major consent decree. The consent decree, between the US Department of Health and Human Services, the Office of Inspector General and the Wisconsin medical device firm Dr. Comfort, runs from March 2011 until May 2017. Under the consent decree, Cerulean will perform regular quality systems management reviews to ensure that Dr. Comfort’s manufacturing processes and controls meet the rules and regulations associated with diabetic footwear medical devices. This review will help ensure compliance with the Medicare reimbursement rules and regulations. “Our goal is to ensure Dr. Comfort’s compliance with HHS requirements,” said Cerulean’s Managing Director and Founder, John Avellanet. “And as with all of the firms we help, we want to make sure to strike a practical balance between compliance and cost. The key is to ensure all the terms of the corporate integrity agreement are met, and preferably in the least burdensome manner. This will help position Dr. Comfort products for success in the wider global marketplace and regulatory landscape.” Much as with its other clients, Cerulean will rely upon a blend of qualitative and quantitative methods to assess compliance. The first step is to take a qualitative approach to analyze the manufacturing and reimbursement processes and controls. Such a review asks a simple question: Should the processes and controls, as written, work? The next step is to take a quantitative approach, reviewing records and data that serve as proof that the processes and controls did, in fact, work as expected. This approach uses record sampling to provide a 95-99% degree of confidence that the processes and controls are working as intended. Cerulean was selected after a lengthy vetting process, including interviews, client referral reviews, and analysis of expertise and experience. About Cerulean Associates LLC Cerulean offers expert FDA quality systems and compliance analysis, remediation and improvement consulting. Emphasis is on cost-effective compliance for growing companies. Cerulean employs only highly experienced industry professionals and experts to consistently prevent and solve compliance challenges with practical solutions. On the web at <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a>. To learn more about Cerulean's litigation support and IRO services, visit: <a href="http://www.ceruleanllc.com/specialized-consulting-services/litigation-support/" rel="nofollow">http://www.ceruleanllc.com/specialized-consulting-services/litigation-support/</a> javellan on "Two FDA Quality Systems Compliance Resources Published" http://biotechbistro.com/forum/topic/two-fda-quality-systems-compliance-resources-published#post-9 Fri, 20 Feb 2009 16:11:11 +0000 javellan 9@http://biotechbistro.com/forum/ Two new FDA quality systems compliance resources – Bulletproof Yourself against FDA Enforcement and FDA Quality Systems Records Requirements for GLPs, GCPs, GMPs – have been published by the SmarterCompliance™ newsletter and Cerulean Associates LLC. Both publications combine recorded executive teleseminars with resource kits of checklists, templates, example FDA warning letters, and other reference material designed to ease implementation of various recommendations and expert advice. Bulletproof Yourself against FDA Enforcement builds on Cerulean’s in-depth industry report from last year, FDA Enforcement Trends 2008-2009, and adds a review of the top 10 agency inspection priorities for domestic US and international sites, four detailed self-assessment checklists, a step-by-step strategy for ensuring positive inspection outcomes, three article reprints, and an hour-long audio-visual analysis of the FDA priorities for 2009 along with recommendations to stay off the FDA radar screen for the next 12-18 months. Also included is a complimentary copy of the industry report, FDA Enforcement Trends 2008-2009. FDA Quality Systems Records Requirements includes a 9-page matrix of FDA records and documentation requirements for firms during GLPs, GCPs, and GMPs, an 11-step strategy overview guide, several self-assessment checklists, a policy framework template, multiple article reprints, and other reference materials. Also included is an hour-length audio-visual recording of last week’s executive teleconference with questions and answers from the audience. Both resource kit publications are available – either in download format or CD and hard copy – through the Cerulean website at <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a>. Cerulean’s next online seminar for executives, Frugal FDA Compliance: Getting More Done with Less, is scheduled for Tuesday, March 24. Want to attend? Visit <a href="http://www.ceruleanllc.com/webinar" rel="nofollow">http://www.ceruleanllc.com/webinar</a> to learn more and register. Cerulean Associates LLC is a private advisory company that helps executives in the pharmaceutical, biotech and device sectors cut costs, streamline quality systems, speed new drug, biologic or device time to market, and protect their intellectual property from theft. Cerulean publishes the SmarterCompliance™ newsletter as part of its SmarterCompliance FDA executive advisory program. On the web at <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a>. ###