BiotechBistro Forums Tag: compliance

BiotechBistro Forums Tag: compliance http://biotechbistro.com/forum/tags/compliance The Business of Biotechnology en-US Wed, 08 Sep 2010 06:42:32 +0000 bbpress 1.0-alpha-4 <![CDATA[Search]]> q http://biotechbistro.com/forum/search.php 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 "GxP Lifeline Interviews John Avellanet on Saving Money and FDA Compliance" http://biotechbistro.com/forum/topic/gxp-lifeline-interviews-john-avellanet-on-saving-money-and-fda-compliance#post-14 Wed, 18 Mar 2009 11:35:58 +0000 javellan 14@http://biotechbistro.com/forum/ In its March issue, GxP Lifeline interviewed Cerulean’s Managing Director, John Avellanet, on the FDA’s increasing concern about data quality, the new FDA Part 11, computer virtualization, and his private SmarterCompliance FDA advisory service for executives in the medical device, pharmaceutical and biotech industries. Executives awaiting news of FDA’s long delayed revisions to 21 CFR Part 11 would do well to subscribe to Cerulean’s FDA intelligence newsletter. As Mr. Avellanet pointed out, “Subscribers expect Part 11 to emerge from the agency this year, have a good feel for what the new Part 11 will include, and have already begun their preparations and project budgeting.” Computer virtualization is much more viable under the revised Part 11, according to Mr. Avellanet. Companies can save 30-80% from their IT budgets depending on how aggressively they pursue virtualization and how prepared they are for the new Part 11. Executives and business owners who participate in Mr. Avellanet’s SmarterCompliance program have gotten at least a 6-12 month drop on their competitors and the FDA’s own inspectors by incorporating Cerulean’s recommendations and insights. Mr. Avellanet said he was most pleased that “because of my constant insistence on cost-efficiency these past 3 years, my clients have been able to weather the current economic conditions quite admirably.” Cerulean has put a copy of the full interview on its website at <a href="http://www.ceruleanllc.com/resources" rel="nofollow">http://www.ceruleanllc.com/resources</a>\Part11_Saving_Money_Virtualization.htm, or readers may visit the GxP Lifeline site for the full March issue. Cerulean's SmarterCompliance program includes a monthly newsletter that 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 medical 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 "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>. ###