BiotechBistro Forums Tag: FDA

BiotechBistro Forums Tag: FDA http://biotechbistro.com/forum/tags/fda The Business of Biotechnology en-US Mon, 06 Feb 2012 09:21:35 +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 "FDA Supplier Management Conference Chaired by Cerulean" http://biotechbistro.com/forum/topic/fda-supplier-management-conference-chaired-by-cerulean#post-165 Wed, 03 Aug 2011 10:02:04 +0000 javellan 165@http://biotechbistro.com/forum/ Cerulean's founder and managing director, John Avellanet, will be chairing the FDA Supplier Quality Management Conference in Bethesda, Maryland on August 9-11, 2011. Hosted by FDAnews, the three-day conference will feature multiple FDA officials discussing current agency regulatory expectations and enforcement around supplier quality management, from preclinical through the postmarket. Industry veterans will provide insight into how their companies - big and small - are tackling the requirements and supplier challenges through presentations and panel discussions. The conference will begin with a half-day workshop by Cerulean's John Avellanet on best practices for controlling supplier risks and implementing a globally harmonized supplier selection and qualification process to meet FDA, Health Canada, EU, Japan, and Australian requirements. Topics for the workshop include: - role of supplier questionnaires - conducting an effective and efficient onsite audit - handling virtual companies as suppliers - specific supplier metrics to gather and trend - records to retain For information on the conference, visit <a href="http://www.SupplierQuality2011.com" rel="nofollow">http://www.SupplierQuality2011.com</a>. For information on talking with Mr. Avellanet about helping your organization implement a compliant and cost-effective supplier oversight program, visit the Cerulean website at <a href="http://www.Ceruleanllc.com" rel="nofollow">http://www.Ceruleanllc.com</a> javellan on "Personalized Medicine and FDA Compliance Mix in New Book" http://biotechbistro.com/forum/topic/personalized-medicine-and-fda-compliance-mix-in-new-book#post-49 Tue, 04 May 2010 08:40:57 +0000 javellan 49@http://biotechbistro.com/forum/ Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine Published by Logos Press, and available nationwide through Barnes & Noble, Amazon.com, Borders Books, and other booksellers, Get Market Now! (342 pages, ISBN: 978-1-934899-12-0, softcover) is designed for executives in the life sciences, from pharmaceutical and biotechnology firms, to medical device and diagnostic companies. Readers of advanced copies have also suggested the book will be “an excellent resource for investors and venture capitalists who need to accurately assess if a company has what it takes in its research & development programs to succeed over the next ten years.” The book provides practical strategies to speed time to market and simply FDA compliance supported with analyses, advice and more than: • 25 figures, diagrams and tables • 15 different checklists and templates • 113 specific tactics • 16 case studies and real-world examples The book's readers also benefit from a dedicated book website - <a href="http://www.Get2MarketNow.com" rel="nofollow">http://www.Get2MarketNow.com</a> - full of downloadable templates, mini-tutorials, and more. Early reviews have cited the book for how well its writing and organization make complex, nuanced subjects easy to understand, from tackling the decline in new medicine innovation and R&D productivity, through increasing business flexibility while still complying with regulations. Journalists who would like a review copy of Get to Market Now!, should contact the publisher Logos Press directly in Washington, D.C.: <a href="mailto:info@logos-press.com">info@logos-press.com</a> or 202-487-0089. Author John Avellanet is the founder and Managing Director of Cerulean Associates LLC, a private regulatory compliance consultancy based in Williamsburg, Virginia. Mr. Avellanet has gained tremendous acclaim on his speeches, workshops and teleconferences for corporate clients and conference venues around the world. Enthusiastic testimonials from attendees cover his speaking page on his website. Conference organizers and program directors repeatedly note that he gets the highest evaluations of any of their speakers. He serves on the boards of several industry associations, and is the FDA compliance columnist for several international industry journals. Every month, he publishes the regulatory intelligence and FDA quality systems advice newsletter for executives, SmarterCompliance™. Learn more about Mr. Avellanet on his award-winning blog, <a href="http://www.ComplianceZen.com" rel="nofollow">http://www.ComplianceZen.com</a>. To engage his private consulting services for FDA-regulated firms, contact him through his company’s website: <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a> ### javellan on "Upcoming Book on Personalized Medicine & FDA Compliance" http://biotechbistro.com/forum/topic/upcoming-book-on-personalized-medicine-amp-fda-compliance#post-20 Fri, 05 Jun 2009 13:02:08 +0000 javellan 20@http://biotechbistro.com/forum/ Cerulean’s managing director, John Avellanet, has signed a contract with Logos Press to write a book covering the compliance and quality systems landscape over the next decade, including the compliance strategies required for new drug and device development and approval in the era of personalized medicines. Based in part on Mr. Avellanet's April talk at the NIH on the future of the biopharmaceutical landscape, and his SmarterCompliance newsletter series on personalized medicine and the role of regulatory compliance, the book provides a strategic review of the compliance and quality systems best practices required for marketplace success over the next decade for biotechnology, pharmaceutical, and medical device firms. The book is sub-divided into three parts: a review of today’s landscape, an analyses of the key challenges likely to dominate over the next ten years, and then a step-by-step strategy covering: • Faster product innovation and development • Medicinal safety and efficacy by design • Cost-effective, lean quality systems • Flexible, regulatory compliance programs As part of the book’s practical, “how to” mindset, readers will be able to access bonus materials, downloads, and supplemental information online through a dedicated book website. Subscribers to Mr. Avellanet’s monthly newsletter, SmarterCompliance, will be able to access pre-publication materials and downloads as part of the lead-in to publication. Publication is slated for May 2010. John Avellanet is the author of more than 100 articles, is the compliance columnist for several international industry journals, and is a former C-level biotech and medical device executive for a Fortune 50 subsidiary. As the co-founder of the private compliance advisory firm, Cerulean Associates LLC, he publishes the monthly executive newsletter, SmarterCompliance™. He is a frequent speaker at corporate workshops, industry conferences, and meets regularly with regulatory officials. Learn more about Mr. Avellanet on his blog, <a href="http://www.ComplianceZen.com" rel="nofollow">http://www.ComplianceZen.com</a>, or through his company’s website: <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a> ### javellan on "New FDA Compliance Blog Published" http://biotechbistro.com/forum/topic/new-fda-compliance-blog-published#post-19 Thu, 21 May 2009 12:58:50 +0000 javellan 19@http://biotechbistro.com/forum/ Cerulean’s managing director, John Avellanet, has finally given in and started a blog of basic FDA advice on quality systems and regulatory compliance: Compliance Zen. Compliance Zen is through TypePad at: <a href="http://www.ComplianceZen.com" rel="nofollow">http://www.ComplianceZen.com</a> Compliance Zen offers practical tips and short “how-to” articles on FDA-related topics such as Quality by Design, lean FDA compliance, records management, and Part 11 compliance. The blog also provides quick management and leadership tips gleaned from a mix of Mr. Avellanet’s personal experiences plus independent business management research. Included in the blog are reviews of leadership books with relevance to compliance, quality systems, and regulatory affairs executives (excerpted from his SmarterCompliance newsletter’s Featured Reading section). John Avellanet is the author of more than 100 articles, is the compliance columnist for several international industry journals, and is a former C-level biotech and medical device executive for a Fortune 50 subsidiary. As the co-founder of a private compliance advisory firm, he publishes the monthly executive newsletter, SmarterCompliance™. He is a frequent speaker at corporate workshops, industry conferences, and meets regularly with regulatory officials. Learn more about Mr. Avellanet on his website: <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a> javellan on "FDA Regulatory Agenda for 2009 Matches Forecast by Cerulean" http://biotechbistro.com/forum/topic/fda-regulatory-agenda-for-2009-matches-forecast-by-cerulean#post-11 Sat, 28 Feb 2009 15:29:53 +0000 javellan 11@http://biotechbistro.com/forum/ Documents released by the US Food and Drug Administration (FDA) last week laid out a schedule of regulatory guidance and agency expectations largely mirroring those forecast in December's SmarterCompliance newsletter. Cerulean Associates LLC publishes the monthly SmarterCompliance newsletter, subscribed to by pharmaceutical, device and biotech executives around the world, and issues an annual forecast for the upcoming year between November and December. "Last year," said Managing Director, John Avellanet, "our forecast gave over 40 recommendations for 2009, most of them just summaries of our more in-depth analyses we published throughout the year in the newsletter. We’re really starting to see subscriptions take off as executives realize the business implications of getting a good 12 to 18 month lead on their competitors and the inspectors." The December SmarterCompliance forecast that the FDA would release a revised version of 21 CFR Part 11, a Good Importer Guidance, Process Validation advice, and more guidance documents supporting the implementation of various aspects of Quality by Design throughout the lifecycle – from preclinical to postmarket – of drugs and biologics. The FDA's agenda as published by the Center for Drug Evaluation Research (CDER) specifies just those items. To help executives who have not had a chance to evaluate SmarterCompliance, Cerulean has made the first half of its December issue available for free download (visit <a href="http://www.ceruleanllc.com/newsletter/" rel="nofollow">http://www.ceruleanllc.com/newsletter/</a>). "Currently," said Mr. Avellanet, "we're turning our attention to the new drug and biologic pipeline implications of personalized medicines; so far we've published dozens of recommendations for our readers along with approximate timelines of marketplace adoption and regulatory rulings." "Let's not kid ourselves," cautioned Mr. Avellanet. "Our February 2008 prediction that some sort of regulatory pathway for follow-on biologics would be in place by the end of this year [2009] may or may not come to pass. The initial budget from the new administration supports such a move, but a whole lot of maneuvering has to go on before a generic biologics pathway exists." Cerulean's SmarterCompliance newsletter mixes compliance and regulatory intelligence with specific recommendations, strategies and quality systems tactics executive teams can adopt. Cerulean surveys a broad set of information sources, including the FDA's own publications, warning letters, daily news, other governmental publications, blogs, and so on to synthesize the information that is then analyzed for subtexts, trends and themes. Journalists who would like a complimentary subscription to Cerulean's SmarterCompliance newsletter can contact Mr. Avellanet directly through the Cerulean website. 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>. ### 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>. ###